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1
Khasanov, R. Sh, and I. A. Kamalov. "Pulmonary embolism prevention in out-patients with malignancies during the first year of follow-up." Kazan medical journal 96, no. 1 (February 15, 2015): 13–16. http://dx.doi.org/10.17750/kmj2015-013.
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Aim. To decrease the one-year mortality rate in out-patients with malignancies undergoing periodic health examination.Methods. The study included 270 patients, who were examined and followed up. The main group included 140 patients, who monthly underwent ultrasonography of inferior vena cava branches during the first year of follow-up. The control group included 130 patients, in whom ultrasonography of inferior vena cava branches was performed only if clinical manifestations of venous thrombosis were registered.Results. Venous thrombosis was diagnosed in 35 patients of the main group, including 21 cases of venous thrombosis at very high risk for embolism. In control group, ultrasonography of inferior vena cava branches was performed in 13 patients who developed clinical manifestations of venous thromboembolic events, in whom 6 patients were diagnosed with deep vein thrombosis of the lower limbs, in 3 patients venous thrombosis was assessed as at very high risk for embolism. In 24 patients (21 in the main group and 3 in the control group), targeted measures to prevent pulmonary embolism were administered, including cava filter implantation, vein ligation above the venous thrombosis at very high risk for embolism site, and crossectomy. The rest of the patients were administered conservative prevention of thromboembolism. In the main group, no deaths associated with pulmonary embolism were registered. In the control group, 19 patients died due to developing pulmonary embolism.Conclusion. Preventive measures for pulmonary embolism, selected according to the results of timely ultrasound diagnosis of venous thrombosis, may reduce the one-year mortality rate in patients with cancer.
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Laporte-Simitsidis, Silvy, Bernard Tardy, Michel Cucherat, Andréa Buchmüller, Daphné Juillard-Delsart, Hervé Decousus, and Patrick Mismetti. "Prevention of Venous Thromboembolism in Internal Medicine with Unfractionated or Low-molecular-weight Heparins: A Meta-analysis of Randomised Clinical Trials." Thrombosis and Haemostasis 83, no. 01 (2000): 14–19. http://dx.doi.org/10.1055/s-0037-1613749.
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SummaryThe prevention of venous thromboembolic disease is less studied in medical patients than in surgery.We performed a meta-analysis of randomised trials studying prophylactic unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in internal medicine, excluding acute myocardial infarction or ischaemic stroke. Deepvein thrombosis (DVT) systematically detected at the end of the treatment period, clinical pulmonary embolism (PE), death and major bleeding were recorded.Seven trials comparing a prophylactic heparin treatment to a control (15,095 patients) were selected. A significant decrease in DVT and in clinical PE were observed with heparins as compared to control (risk reductions = 56% and 58% respectively, p <0.001 in both cases), without significant difference in the incidence of major bleedings or deaths. Nine trials comparing LMWH to UFH (4,669 patients) were also included. No significant effect was observed on either DVT, clinical PE or mortality. However LMWH reduced by 52% the risk of major haemorrhage (p = 0.049).This meta-analysis, based on the pooling of data available for several heparins, shows that heparins are beneficial in the prevention of venous thromboembolism in internal medicine.
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Intiyanaravut, Tawan, Nimit Thongpulsawasdi, Napol Sinthuvanich, and Sasikarn Songtaweesap. "Efficacy and safety of dabigatran for venous thrombosis prophylaxis after knee replacement surgery in Thai patients: a prospective non-randomized controlled trial." Asian Biomedicine 13, no. 6 (June 25, 2020): 217–23. http://dx.doi.org/10.1515/abm-2019-0064.
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AbstractBackgroundDabigatran, a direct oral anticoagulant, has been approved for the prevention of venous thromboembolism (VTE) after orthopedic surgery in many countries. The efficacy and safety of this agent were most studied in Western countries.ObjectiveTo assess the efficacy and safety of dabigatran in preventing venous thromboembolic diseases after total knee arthroplasty (TKA) in Asian patients.MethodsWe conducted a prospective nonrandomized controlled study in Thai patients undergoing TKA. Thirty-two patients received 220 mg of dabigatran once daily for 14 days as thromboprophylaxis and 32 patients in the control group received none. The primary efficacy outcome was deep vein thrombosis (DVT), which was identified by color Doppler ultrasonography and/or diagnosed pulmonary embolism (PE). The primary safety outcomes were major bleeding and clinically relevant nonmajor bleeding events.ResultsThere were no DVTs or PEs diagnosed in either group. The difference in the composite incidence of major and clinically relevant nonmajor bleedings between the dabigatran and control groups did not reach significant (6.2% vs. 0%, P = 0.15).ConclusionDabigatran might have no clear benefit for the prevention of VTE after TKA in Thai patients. We do not recommend the routine use of dabigatran as a chemical thromboprophylaxis after TKA in Thai patients. To determine the safety profile, further study with larger sample sizes is required.
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Ravikumar, Raveena, Katherine J. Williams, Adarsh Babber, Hayley M. Moore, Tristan RA Lane, Joseph Shalhoub, and Alun H. Davies. "Neuromuscular electrical stimulation for the prevention of venous thromboembolism." Phlebology: The Journal of Venous Disease 33, no. 6 (June 13, 2017): 367–78. http://dx.doi.org/10.1177/0268355517710130.
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Objective Venous thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, is a significant cause of morbidity and mortality, affecting one in 1000 adults per year. Neuromuscular electrical stimulation is the transcutaneous application of electrical impulses to elicit muscle contraction, preventing venous stasis. This review aims to investigate the evidence underlying the use of neuromuscular electrical stimulation in thromboprophylaxis. Methods The Medline and Embase databases were systematically searched, adhering to PRISMA guidelines, for articles relating to electrical stimulation and thromboprophylaxis. Articles were screened according to a priori inclusion and exclusion criteria. Results The search strategy identified 10 randomised controlled trials, which were used in three separate meta-analyses: five trials compared neuromuscular electrical stimulation to control, favouring neuromuscular electrical stimulation (odds ratio of deep vein thrombosis 0.29, 95% confidence interval 0.13–0.65; P = .003); three trials compared neuromuscular electrical stimulation to heparin, favouring heparin (odds ratio of deep vein thrombosis 2.00, 95% confidence interval 1.13–3.52; P = .02); three trials compared neuromuscular electrical stimulation as an adjunct to heparin versus heparin only, demonstrating no significant difference (odds ratio of deep vein thrombosis 0.33, 95% confidence interval 0.10–1.14; P = .08). Conclusion Neuromuscular electrical stimulation significantly reduces the risk of deep vein thrombosis compared to no prophylaxis. It is inferior to heparin in preventing deep vein thrombosis and there is no evidence for its use as an adjunct to heparin.
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Kulesh, A. A., D. A. Demin, and O. I. Vinogradov. "Cryptogenic stroke. Part 1: Aorto-arterial embolism." Meditsinskiy sovet = Medical Council, no. 4 (April 20, 2021): 78–87. http://dx.doi.org/10.21518/2079-701x-2021-4-78-87.
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The article discusses the concept of embolic stroke from an unspecified source and the role of aorto-arterial embolism in its development. Potential causes of embolic cryptogenic stroke such as aortic atheromatosis, non-stenotic atherosclerosis of the cervical arteries, carotid web and intracranial atherosclerosis are discussed in detail. The discussion of each cause covers epidemiology, pathogenesis, and current approaches to diagnosis and secondary prevention. The diagnostic search is presented in the form of an algorithm. To identify aorto-arterial sources of embolism and to determine their clinical significance, a comprehensive examination including CT angiography with targeted assessment of the aortic arch, transesophageal echocardiography, MRI of the arterial wall and transcranial Doppler is required. When mechanical thrombectomy is performed, histological examination of the thromboembolus is advisable. Given that atherosclerosis is usually systemic, the search for a possible cause of aorto-arterial embolism should be a diagnostic priority in patients with cryptogenic stroke and other arterial (coronary, lower extremity) lesions. With regard to secondary prevention of cryptogenic stroke in the presence of potential sources of aorto-arterial embolism, the principle ‘the more embologenic the source, the more aggressive the prevention’ applies. The arsenal of secondary prevention includes strategies such as strict control of vascular risk factors, achieving target blood pressure, short- and medium-term dual antiplatelet therapy, and intensive hypolipidemic therapy. Surgical prophylaxis is warranted for stroke against a carotid background, the efficacy of which in non-stenotic atherosclerosis requires early evaluation in randomised trials. Each potential cause of cryptogenic stroke considered is illustrated by a clinical example.
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Grishchenko, O. V., and V. V. Bobrytska. "Thromboembolic complications prevention in the obstetric practice." HEALTH OF WOMAN, no. 1(117) (February 28, 2017): 19–24. http://dx.doi.org/10.15574/hw.2017.117.19.
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The objective: To evaluate the clinical efficacy and safety of Enoxaparin-Pharmex for the prevention of thrombotic complications (pulmonary embolism) in the postoperative period in patients with moderate risk of these complications. Patients and methods. The study included 50 women after a caesarean section had an average degree of risk of pulmonary embolism. Patients were divided into the main group (n=25) and control group (n=25) in accordance with the treatment: patients of the main group received postoperative Еnoxaparin- Pharmex, group comparisons enoxaparin sodium (brand foreign manufacturer’s). Patients in both groups received the drug at a dose of 20 mg for 5 days, 1 time per day subcutaneously. Results. The research data analysis showed identity results of hemostasiogram of patients in the main group and the comparison group, no side effects after treatment in both groups. Conclusion. The clinical studies suggest the drug Enoxaparin-Pharmex is effective, safe LMWH, which can be used to prevent troboembolic complications, including post-operative treatment in obstetric practice. Spectrum of Enoxaparin-Pharmex can be extended to the prevention and treatment of thromboembolic conditions of varying severity with appropriate doses of the drug. Key words: Enoxaparin-Pharmex, prevention of pulmonary embolism.
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Sukovatykh, Boris Semenovich, Mikhail Borisovich Sukovatykh, and Sergey Olegovich Perkov. "Efficacy and Safety of New Oral Anticoagulants in the Prevention of Venous Thromboembolism after Orthopaedic Surgery." Vestnik of Experimental and Clinical Surgery 10, no. 3 (November 19, 2017): 212–17. http://dx.doi.org/10.18499/2070-478x-2017-10-3-212-217.
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Relevance. Despite of a specific prophylaxis, the thromboembolic complications occur in 20-25% of patients after orthopedic surgeries. In those who do not receive the prophylaxis the complications rate is even higher taking up to 45-70% thereby putting the complications into second place after infection complications.
Objective. To compare the efficacy and safety of dabigatran etaxilate and rivaroxaban in prophylaxis and treatment of the venous thromboembolism after hip and knee arthroplasty.
Materials and methods. An analysis of prophylaxis and treatment of venous thromboembolism in 104 patients who had had hip and knee arthroplasty has been accomplished. All patients were randomized into two groups. 51 patients were enrolled into the first (control) group where 220 mg per day dabigatran etexilat therapy was used. The second (investigated) group included 53 patients who received 10 mg per day rivaroxabane therapy. A year after surgery the quality of life of patients was assessed using CIVIQ-20 and SF-36 questioners.
Results and their discussion. Venous thromboembolic complications had occurred in 18 (17,3%) of patients equally in the first and second group. Isolated common femoral vein thrombosis was found in 8 (7,7%), and in 3 (2,9%) patients it was associated with pulmonary embolism. Popliteal and tibial vein thrombosis was detected in 7 (6,7%) patients. Internal bleeding complications were found in 9 (8,6%) patients with venous thrombosis. The complications were more common in a second group (higher by 1,7%). In 7 (6,7%) cases the complications had no clinical significance. Only in 2 (1,9%) patients (one case in each group) were documented severe hemorrhages, that needed hemostatic therapy. A year after surgery the quality of life of patients was assessed using specifically oriented CIVIQ-20 and SF-36 international questioners for chronic venous insufficiency. The evidence based differences between two groups were not discovered.
Conclusion. Dabigatran etexilate as well as rivaroxaban can be used for prophylaxis of the venous thromboembolism after orthopedic surgeries.
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Nurmohamed, M. T., A. M. van Riel, C. M. A. Henkens, M. M. W. Koopman, G. T. H. Que, P. D’Azemar, H. R. Büller, et al. "Low Molecular Weight Heparin and Compression Stockings in the Prevention of Venous Thromboembolism in Neurosurgery." Thrombosis and Haemostasis 75, no. 02 (1996): 233–38. http://dx.doi.org/10.1055/s-0038-1650250.
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SummaryPerioperative anticoagulant prophylaxis for postoperative venous thromboembolism (VTE) in neurosurgical patients has not gained wide acceptance due to the fear of intracranial bleeding. Physical methods give a worthwhile reduction of postoperative VTE but there still remains a substantial residual incidence. In other clinical indications, low molecular weight heparins have proven to be effective for prophylaxis of VTE when administered postoperatively, with the advantage of no bleeding enhancement during surgery.Therefore, we performed a multicentre, randomized, double-blind trial in neurosurgical patients to investigate the efficacy and safety of adding a low molecular weight heparin (LMWH), nadroparin, initiated postoperatively, to graduated compression stockings in the prevention of VTE. Deep-vein thrombosis was detected by mandatory venography. Bleeding was determined according to pre-defined objective criteria for major and minor episodes.An adequate bilateral venogram was obtained in 166 of 241 LMWH patients (68.9%) and 179 of 244 control patients (73.4%). A total of 31 of 166 LMWH patients (18.7%) and 47 of 179 control patients (26.3%) had VTE up to Day 10 postoperatively (p = 0.047). The relative risk reduction (RRR) was 28.9%. The rates for proximal deep-vein thrombosis/pulmonary embolism were 6.9% and 11.5% for the two groups, respectively (RRR: 40.2%; p = 0.065).Secondary analyses involved all VTE up to day 56 post-surgery which was detected in 33 patients of 241 in the LMWH group (13.7%) and 51 of 244 control patients (20.9%; RRR 34.5%; p = 0.018). The corresponding percentages for proximal deep-vein thrombosis/pulmonary embolism were 5.8% and 10.2% for the two groups, respectively, giving a RRR of 43.3%; p = 0.036. Major bleeding complications, during the treatment period, occurred in six low molecular weight heparin treated patients (2.5%) and in two control patients (0.8%); p = 0.087.A higher mortality was observed in the low molecular weight heparin group over the 56-day follow-up period (22 versus 10; p = 0.026). However, none of these deaths was judged by a blinded adjudication committee to be related to the study drug.In conclusion, this study demonstrates that the low molecular weight heparin, nadroparin, added to graduated compression stockings results in a clinically significant decrease in VTE without inducing any significant increase of major bleeding.
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Merino, Jose L., and Jose López-Sendón. "New Drugs for Thromboembolic Prevention in Atrial Fibrillation." European Cardiology Review 6, no. 4 (2010): 64. http://dx.doi.org/10.15420/ecr.2010.6.4.64.
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Atrial fibrillation (AF) is the most frequent sustained arrhythmia and its prevalence is increasing in developed countries. This progressive increase and the negative impact of this arrhythmia on the patient’s prognosis make AF one of the main healthcare problems faced today. This has led to intense research into the main aspects of AF, one of them being thromboembolism prevention. AF patients have a four to five times higher risk of stroke than the general population. Several factors increase thromboembolic risk in patients with AF and the use of risk scores, such as the Congestive Heart Failure, Hypertension, Age Greater than 75, Diabetes, and Prior Stroke or Transient Ischemic Attack (CHADS2), have been used to identify the best candidates for anticoagulation. Antithrombotic drugs are the mainstay of therapy for embolic prevention. The clinical use of these drugs is based on the risk–benefit ratio, where benefit is the reduction of stroke and systemic embolic events and risk is mostly driven by the increase in bleeding events. Generally, antiplatelets are indicated for low-risk patients in light of the fact anticoagulants are the drug of choice for moderate- or high-risk patients. Vitamin K antagonists have been the only option for oral anticoagulation for the last 50 years. However, these drugs have many pharmacodynamic and pharmacokinetic problems. The problems of anticoagulation with vitamin K antagonists have led to the investigation of new drugs that can be administered orally and have a better dose–response relationship, a shorter half-life and, in particular, higher efficacy and safety without the need for frequent anticoagulation controls. The drugs that have been studied most thoroughly in patients with AF are inhibitors of the activated coagulation factor X and inhibitors of coagulation factor II (thrombin), including ximelagatran and dabigatran. In addition, non-pharmacological therapies have been developed to prevent recurrent embolism in certain patient populations.
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Spyropoulos, Alex C. "The management of venous thromboembolism in hospitalized patients with COVID-19." Blood Advances 4, no. 16 (August 25, 2020): 4028. http://dx.doi.org/10.1182/bloodadvances.2020002496.
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Abstract The high incidence of thromboembolic disease, and in particular venous thromboembolism (VTE), has emerged as an important consideration in hospitalized and critically ill patients with coronavirus disease 2019 (COVID-19). The coagulopathy of COVID-19 is postulated to result from interactions of the inflammatory and immune systems with the coagulation system, manifesting as a cytokine storm associated with hyperinflammation and coagulation and platelet activation. Unique characteristics of VTE in hospitalized and critically ill patients with COVID-19 include the high incidence of VTE (and especially pulmonary embolism) when compared with historical controls; the finding of in situ pulmonary embolism associated with microthrombi, which suggests a thrombotic microangiopathic process in addition to classic macrovessel disease; and, most important from a clinical perspective, the unusually high rate of VTE that has been reported despite standard thromboprophylaxis. This raises the possibility that intermediate or weight-based heparin dosing may be more effective than fixed dosing for thromboprophylaxis in high-risk subsets of patients hospitalized with COVID-19. There have been several guidance statements focusing on the management of VTE in hospitalized and critically ill patients with COVID-19, including the most recent statement by the Scientific and Standardization Committee of the International Society of Thrombosis and Haemostasis, which includes comprehensive guidance on the diagnosis, prevention, and treatment of VTE in this patient population. Ongoing randomized trials that address key clinical questions, especially more intense thromboprophylactic strategies and novel antithrombotic approaches, have the potential to reduce the morbidity and mortality from VTE in hospitalized and critically ill patients with COVID-19.
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Komsa-Penkova, Regina, Pencho T. Tonchev, Katya S. Kovacheva, Galya B. Georgieva, Yavor Y. Ivanov, Petar D. Ivanov, Georgi M. Golemanov, and Sergey D. Iliev. "Predisposition to Thrombophilia and Hypofibrinolysis in Pulmonary Embolism: Analysis of Inherited Factors." Journal of Biomedical and Clinical Research 6, no. 2 (December 1, 2013): 73–81. http://dx.doi.org/10.1515/jbcr-2015-0105.
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Summary Pulmonary embolism (PE) is a relatively common cardiovascular emergency, though its exact incidence is difficult to assess. Accurate diagnosis is critical because of the high 30-day mortality in patients in whom the diagnosis is missed on admission. Doubt for PE is often raised by the presence of risk factors for venous thromboembolism (VTE), which are categorized into inherited and acquired. Among these, the importance of inherited/genetic thrombophilic factors is increasingly recognized. The most frequent markers of inherited thrombophilia are Factor V Leiden (FVL) and G2021OA prothrombin gene mutation. Among the inherited factors causal to thrombophilia, the C677T variant in methylentetrahydrofolate reductase (MTHFR) gene as well as factors like P1A1/P1A2 polymorphism in platelet glycoprotein Ilb/IIIa (P1A2) and hypofibrinolytic polymorphism 4G/4G in PAI-1 gene are discussed with controversial results. In our study, thrombophilic and hypofibrinolytic genetic variants were identified in 54.2% of 115 patients with PE. The most common significant genetic defects were FVL- 16.5% in patients versus 6.2% in controls (OR=3.102; p=0.05), G20210A PT 5.7% versus 2.1% (OR=2.983; p>0.05). P1A2 was found in 27.3% patients versus 19.9% in controls (OR= 1.523, p>0.05) and PAM 27.8% versus 22.6% (OR =1.501 p>0.05). MTHFR C677T carriage was inverse: 6.7% in patients versus 13.4% in controls. (OR=0.461 p=0.05). Of all the patients studied, 15.65% had a history of recurrent embolic incidents. The risk of recurrence was higher for the carriers of FVL and G20210A prothrombin gene mutation. The association between carriage of thrombophilic genetic factor and the early onset of the first embolic episode was found in the patients with PE. The awareness of risk factors and risk stratification is a critical issue in treatment and prevention policy. Preventive measures should be taken in particular medical conditions.
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Sundararajan, Srinath, Mugilan Poongkunran, Chithra Poongkunran, Arun Kannan, and Saravananan Balamuthusamy. "Efficacy and Bleeding Risk of Newer Anticoagulants Compared to Conventional Treatment in Patients with Chronic Kidney Disease- a Meta-Analysis of Randomized Controlled Trials." Blood 126, no. 23 (December 3, 2015): 2325. http://dx.doi.org/10.1182/blood.v126.23.2325.2325.
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Abstract Background Multiple newer oral anticoagulants (NOAC) are currently approved for the prevention, treatment of venous thromboembolism (VTE) and prevention of stoke in atrial fibrillation (AF). Most of the clinical trials with NOAC have excluded patients with severe renal insufficiency. There is a paucity of safety and efficacy data of NOAC in comparison with conventional treatment (CT) in patients with mild or moderate renal impairment. We performed a meta-analysis of the randomized control trials (RCTs) comparing NOAC to CT in patients with renal insufficiency to understand the safety and efficacy of NACs. Methods Medline, PubMed, EMBASE, EBSCO, CINAHL and Cochrane databases were queried with the keywords - "newer anticoagulants", "renal insufficiency", "dabigatran", "rivaroxaban", "apixaban", and "edoxaban". RCTs comparing NOAC to CT (warfarin, low molecular weight heparin, heparin, aspirin or placebo) were included. Non-randomized single arm trials were excluded. Authors of RCTs with missing pertinent data were contacted through electronic mail. The safety end point analyzed was clinically significant or major bleeding risk. The efficacy end points analyzed were incidence of arterial embolism in AF studies and venous thromboembolism in VTE studies. European Medical Agency classification of renal insufficiency was used, with mild renal insufficiency defined as estimated glomerular filtration rate (eGFR) from 50 to 79 and moderate renal insufficiency defined as eGFR of 30 to 49 and severe renal insufficiency defined as eGFR< 30. Results Sixteen RCTs with 115,147 patients fulfilled our inclusion criteria. Rivoroxaban, apixaban, edoxaban and dabigatran were the newer anticoagulants used in these 16 RCTs. Among these, 48,403 patients had either mild or moderate renal insufficiency. Patients with mild renal insufficiency treated with NAOC had lower bleeding risk [Odds ratio 0.81(CI 0.72-0.90) p<0.0001], lower incidence of arterial thromboembolism [Odds ratio 0.74(CI 0.64-0.85) p<0.0001] compared to conventional treatment. Patients with moderate renal insufficiency treated with NAOC had lower incidence of arterial thromboembolism [Odds ratio 0.74(CI 0.62-0.89) p=0.001] and a trend towards lower bleeding risk [Odds ratio 0.89(CI 0.66-1.18) p=0.41], compared to conventional treatment. Also, a trend of lowered VTE incidence was observed with NOAC compared to conventional treatment in patients with mild [Odds ratio 0.70(CI 0.46 to 1.070) p=0.1] as well moderate [Odds ratio 0.69(CI 0.34 to 1.41) p=0.31] renal insufficiency. Conclusion: Newer anticoagulants have decreased odds for VTE, arterial embolism and bleeding in patients with mild to moderate renal insufficiency compared to conventional treatment. Disclosures No relevant conflicts of interest to declare.
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STANESCU, Ioana C., Angelo BULBOACA, Dana Marieta FODOR, Camelia Diana OBER, Gabriel GUSETU, and Gabriela DOGARU. "Role of rehabilitation in prevention of early thromboembolic complications in hemorrhagic stroke." Balneo Research Journal 10, Vol.10, No.3 (September 3, 2019): 311–16. http://dx.doi.org/10.12680/balneo.2019.274.
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Hemorrhagic strokes (ICH) affects mainly young active people, with increasing incidence in developing countries. Mortality is high in acute phase, and patients are prone to complications related to stroke itself and to coexisting medical conditions. Patients with ICH are at high risk in developing deep venous thrombosis (DVT) with secondary pulmonary embolism (PE). Prevention of venous thrombotic events in hemorrhagic stroke patients requires intermittent pneumatic compression and preventive doses of low molecular weight heparins (LMWH) in high-risk patients. If DVT and /or PE occurs, the therapeutic management should balance the risk of recurrent cerebral bleeding and the life-threatening risk of PE, making the decision to start anticoagulation challenging. We present a case of a young patient with a large hypertensive capsulo-lenticular hemorrhage, who was diagnosed with pulmonary embolism 21 days after stroke onset. The decision was for anticoagulant treatment initial with LWMH, and switch to direct oral anticoagulants (DOAC) after 10 days; strict control of vascular risk factors of the patients (hypertension, diabetes and obesity) was achieved. Rehabilitation treatment, delayed until day 21, was recommended with progressive intensity. Evolution of the patient was favorable, with complete hematoma resorbtion under DOAC treatment at 10 weeks follow-up and important motor recovery. Rehabilitation program was intensive during this interval, and strongly contributive to neurologic improvement.
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Prell, Julian, Grit Schenk, Bettina-Maria Taute, Christian Scheller, Christian Marquart, Christian Strauss, and Stefan Rampp. "Reduced risk of venous thromboembolism with the use of intermittent pneumatic compression after craniotomy: a randomized controlled prospective study." Journal of Neurosurgery 130, no. 2 (February 2019): 622–28. http://dx.doi.org/10.3171/2017.9.jns17533.
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OBJECTIVEThe term “venous thromboembolism” (VTE) subsumes deep venous thrombosis (DVT) and pulmonary embolism. The incidence of DVT after craniotomy was reported to be as high as 50%. Even clinically silent DVT may lead to potentially fatal pulmonary embolism. The risk of VTE is correlated with duration of surgery, and it appears likely that it develops during surgery. The present study aimed to evaluate intraoperative use of intermittent pneumatic compression (IPC) of the lower extremity for prevention of VTE in patients undergoing craniotomy.METHODSA total of 108 patients undergoing elective craniotomy for intracranial pathology were included in a single-center controlled randomized prospective study. In the control group, conventional compression stockings were worn during surgery. In the treatment group, IPC of the calves was used in addition. The presence of DVT was evaluated by Doppler sonography pre- and postoperatively.RESULTSIntraoperative use of IPC led to a significant reduction of VTE (p = 0.029). In logistic regression analysis, the risk of VTE was approximately quartered by the use of IPC. Duration of surgery was confirmed to be correlated with VTE incidence (p < 0.01); every hour of surgery increased the risk by a factor of 1.56.CONCLUSIONSIntraoperative use of IPC significantly lowers the incidence of potentially fatal VTE in patients undergoing craniotomy. The method is easy to use and carries no additional risks.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class I.Clinical trial registration no.: DRKS00011783 (https://www.drks.de)
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Sotnikov, A. V., M. V. Melnikov, V. A. Marinin, Yu V. Kisil, and K. V. Samko. "Prevention of embolism in patients with atrial fibrillation after resection of left atrium appendage during open heart surgery (pilot study)." HERALD of North-Western State Medical University named after I.I. Mechnikov 10, no. 2 (December 15, 2018): 52–57. http://dx.doi.org/10.17816/mechnikov201810252-57.
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Aim. To assess the potential of prevention cardiogenic embolism by resection of left atrium appendage (LAA) during open heart surgery in patients with atrial fibrillation (AFib). Materials and methods. Study design - cohort prospective. Study group consisted of 19 patients with AFib whom during open heart surgery for coronary and/or valvular disease additional radical resection of LAA was made. After removal of the appendage two-layer linear suture to left atrium was performed without leaving a stump. Control group consisted of 20 patients with AFib, in whom during open heart surgery LAA remained intact. Long-term results were studied using CROQ telephone questionnaire. Results. There was no hospital mortality in both groups. Long-term results in control group were followed up to 6 years, in study group up to 2 years. Radical resection of LAA in patients with AFib reduced the risk of thromboembolic events in long-term period. In control group there were 4 strokes (2 of them were fatal), but no strokes in study group (p < 0,05). Conclusion. Radical resection of LAA in patients with AFib during open heart surgery for coronary and/or valvular disease prevents cardiogenic arterial embolism. (For citation: Sotnikov AV, Melnikov MV, Marinin VA, et al. Prevention of embolism in patients with atrial fibrillation after resection of left atrium appendage during open heart surgery (pilot study). Herald of North-Western State Medical University named after I.I. Mechnikov. 2018;10(2):52-57. doi: 10.17816/mechnikov201810252-57).
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Kuznetsov, M. R., I. V. Reshetov, B. B. Orlov, A. A. Khotinsky, A. A. Atayan, and M. A. Shchedrinа. "Predictors of Chronic Thromboembolic Pulmonary Hypertension." Kardiologiia 58, no. 12 (December 25, 2018): 60–65. http://dx.doi.org/10.18087/cardio.2018.12.10206.
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Purpose:to elucidate predictors of development of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary artery thromboembolism (PTE).Material and methods. We included in this study 210 patients hospitalized with diagnosis of submassive and massive PTE from 2013 to 2017. In 1 to 3 years after initial hospitalization these patients were invited for control examination. According to results of this examination patients were divided into two groups: with (group 1, n=45) and without (group 2, n=165) signs of CTEPH. Severity of pulmonary artery vascular bed involvement was assessed by multislice computed tomography (MSCT) angiography and lung scintigraphy. For detection of thrombosis in the inferior vena cava system we used ultrasound angioscanning. Examination also included echocardiography.Results.In the process of mathematical analysis, the following risk factors for the development of CTEPH embolism were determined: duration of thrombotic history (group 1 – 13.70±2.05 days, group 2– 16.16±1.13 days, p=0.015), localization of venous thrombosis in the lower extremities (the most favorable – shin veins, popliteal, and common femoral veins, unfavorable – superficial femoral vein). The choice of the drug for thrombolytic and anticoagulant therapy: streptokinase and urokinase were significantly more effective than alteplase, rivaroxaban was superior to the combination of unfractionated or low molecular weight heparins with warfarin. Also, risk factors for the development of CTEPH were the initial degree of pulmonary hypertension and tricuspid insufficiency, as well as the positive dynamics of these indicators at the background of thrombolytic or anticoagulant therapy. Of concomitant diseases, significant risk factors for development of CTEPH were grade 3 hypertensive disease, diabetes mellitus, postinfarction cardiosclerosis. On the other hand, age, gender, degree of severity at the time of admission, presence of infarction pneumonia, surgical prevention of recurrent pulmonary embolism, number of pregnancies and deliveries, history of trauma and malignancies, cardiac arrhythmias produced no significant impact on the development of CTEPH.
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Palosuo, Timo, Jarmo Virtamo, Jari Haukka, Philip R. Taylor, Kimmo Aho, Marja Puurunen, and Outi Vaarala. "High Antibody Levels to Prothrombin Imply a Risk of Deep Venous Thrombosis and Pulmonary Embolism in Middle-aged Men." Thrombosis and Haemostasis 78, no. 04 (1997): 1178–82. http://dx.doi.org/10.1055/s-0038-1657711.
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SummaryAntibodies against phospholipid-binding plasma proteins, such as β2-glycoprotein I (β2-GPI) and prothrombin, are associated with thromboembolic events in patients with systemic lupus erythematosus and also in subjects with no evident underlying diseases. We wanted to examine whether increased levels of antibodies to negatively-charged phospholipids (cardiolipin), to phospholipid-binding plasma proteins β2-GPI and prothrombin and to oxidised low-density lipoprotein (LDL) were associated with risk of deep venous thrombosis or pulmonary embolism in subjects with no previous thrombosis. The antibodies were measured in stored serum samples from 265 cases of deep venous thrombosis of the lower extremity or pulmonary embolism occurring during a median follow-up of about 7 years and from 265 individually matched controls. The study subjects were middle-aged men participating in a cancer prevention trial of alpha-tocopherol and beta-carotene and the cases of thromboembolic events were identified from nationwide Hospital Discharge Register.The risk for thrombotic events was significantly increased only in relation to antiprothrombin antibodies. As adjusted for body mass index, number of daily cigarettes and history of chronic bronchitis, myocardial infarction and heart failure at baseline, the odds ratio per one unit of antibody was 6.56 (95% confidence interval 1.73-25.0). The seven highest individual optical density-unit values of antiprothrombin antibodies were all confined to subjects with thromboembolic episodes.In conclusion, the present nested case-control study showed that high autoantibody levels against prothrombin implied a risk of deep venous thrombosis and pulmonary embolism and could be involved in the development of the thrombotic processes.
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Ambrosino, Pasquale, Luciano Tarantino, Giovanni Di Minno, Mariano Paternoster, Vincenzo Graziano, Maurizio Petitto, Aurelio Nasto, and Matteo Nicola Di Minno. "The risk of venous thromboembolism in patients with cirrhosis." Thrombosis and Haemostasis 117, no. 01 (2017): 139–48. http://dx.doi.org/10.1160/th16-06-0450.
Full textAbstract:
SummarySome studies suggest that patients with cirrhosis have an increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE). Unfortunately, available data on this association are contrasting. It was the objective of this study to perform a systematic review and meta-analysis of literature to evaluate the risk of venous thromboembolism (VTE) associated with cirrhosis. Studies reporting on VTE risk associated with cirrhosis were systematically searched in the PubMed, Web of Science, Scopus and EMBASE databases. Eleven studies (15 data-sets) showed a significantly increased VTE risk in 695,012 cirrhotic patients as compared with 1,494,660 non-cirrhotic controls (OR: 1.703; 95 %CI: 1.333, 2.175; P<0.0001). These results were confirmed when specifically considering the risk of DVT (7 studies, OR: 2.038; 95 %CI: 1.817, 2.285; P<0.0001) and the risk of PE (5 studies, OR: 1.655; 95 %CI: 1.042, 2.630; p=0.033). The increased VTE risk associated with cirrhosis was consistently confirmed when analysing nine studies reporting adjusted risk estimates (OR: 1.493; 95 %CI: 1.266, 1.762; p<0.0001), and after excluding studies specifically enrolling populations exposed to transient risk factors for VTE (OR: 1.689; 95 %CI: 1.321, 2.160; p<0.0001). Meta-regression models suggested that male gender may significantly impact on the risk of VTE associated with cirrhosis. Results of our meta-analysis suggest that cirrhotic subjects may exhibit an increased risk of VTE. This should be considered to plan specific prevention strategies in this clinical setting.Supplementary Material to this article is available online at www.thrombosis-online.com.
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Schulman, Sam, Henry Eriksson, Ajay Kakkar, Clive Kearon, Sebastian M. Schellong, Patrick Mismetti, Martin Feuring, Stefan Hantel, Joerg Kreuzer, and Samuel Z. Goldhaber. "Post-Hoc Analysis of RE-MEDY™ Demonstrates Significant Real-World Net Clinical Benefit for Dabigatran Versus Warfarin in Prevention of Secondary Venous Thromboembolism." Blood 124, no. 21 (December 6, 2014): 4270. http://dx.doi.org/10.1182/blood.v124.21.4270.4270.
Full textAbstract:
Abstract Background: The double-blind, parallel-group, noninferiorityRE-MEDY™ study comparing the direct oral thrombin inhibitor dabigatran etexilate to warfarin in the prevention of secondary venous thromboembolism (VTE) showed non-inferiority of dabigatran to warfarin in both hazard ratio (HR) and risk difference for recurrent symptomatic VTE and related deaths. The benefit-risk balance of dabigatran compared to warfarin in secondary VTE prevention can be further explored by evaluating the net clinical benefit (NCB). Methods: Patients with a diagnosis of VTE received dabigatran 150 mg twice daily (n = 1430), or warfarin adjusted to maintain an international normalized ratio (INR) of 2.0–3.0 (n = 1426), for an additional period of 6–36 months after 3–12 months of anticoagulant therapy. NCB in the RE-MEDY™ study was evaluated narrowly by (1) analyzing nonfatal recurrent VTE, nonfatal myocardial infarction (MI), nonfatal stroke, nonfatal systemic embolism, all-cause death, and major bleeding events (MBEs), and broadly by (2) including clinically relevant bleeding events (CRBEs). The latter is considered more applicable to real-world clinical practice. NCB was also assessed by center time in therapeutic range (cTTR – the mean TTR of all warfarin patients in each center). Results: The narrow NCB (1) was similar between dabigatran and warfarin (HR 1.05, 95% confidence interval [CI]: 0.75–1.46). For the broader NCB (2), a statistically significant difference was evident favoring dabigatran over warfarin (HR 0.73, 95% CI: 0.59–0.91). Stratification of the NCB by cTTR quintiles demonstrated that the positive benefit of dabigatran over warfarin was preserved when comparing to warfarin patients with a good INR control. Conclusion: In the assessment of real-world net clinical benefit in the prevention of secondary VTE, dabigatran was superior to warfarin, irrespective of INR control in the warfarin patients. Table. Net clinical benefit for dabigatran versus warfarin in pooled analyses of RE-MEDY™ Dabigatran (N=1430) n (%) Warfarin (N=1426) n (%) HR (95% CI) p value for superiority Narrow: Composite cardiovascular endpoint* and MBEs (NCB 1) 72 (5.0) 69 (4.8) 1.05 (0.75–1.46) 0.7818 Broad: Composite cardiovascular endpoint*, MBEs and CRBEs (NCB 2) 136 (9.5) 183 (12.8) 0.73 (0.59, 0.91) 0.0058 *Nonfatal recurrent venous thromboembolism (VTE), nonfatal myocardial infarction (MI), nonfatal stroke, nonfatal systemic embolism, all-cause death. Disclosures Schulman: Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Bayer HealthCare: Consultancy, Honoraria, Research Funding. Eriksson:Boehringer Ingelheim: Consultancy; BMS: Consultancy; Pfizer: Consultancy. Kakkar:Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Daiichi: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding; Eisai: Consultancy, Honoraria, Research Funding. Kearon:Bayer Healthcare: Consultancy; Boehringer Ingelheim (Canada): Consultancy. Schellong:Boehringer Ingelheim: advisory boards Other, Consultancy, Honoraria; Bayer Healthcare: advisory boards, advisory boards Other, Consultancy, Honoraria; Daiichi Sankyo: advisory boards, advisory boards Other, Honoraria; BMS/Pfizer: Honoraria. Feuring:Boehringer Ingelheim: Employment. Hantel:Boehringer Ingelheim: Employment. Kreuzer:Boehringer Ingelheim: Employment. Goldhaber:Boehringer Ingelheim: Consultancy; Daiichi: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Janssen: Consultancy; Merck: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Sanofi-Aventis: Consultancy.
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Paquette, Miney, Daniel M. Witt, Anne Holbrook, Jane Skov, Jack Ansell, Holger J. Schünemann, Wojtek Wiercioch, and Robby Nieuwlaat. "A systematic review and meta-analysis of supplemental education in patients treated with oral anticoagulation." Blood Advances 3, no. 10 (May 28, 2019): 1638–46. http://dx.doi.org/10.1182/bloodadvances.2019000067.
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Abstract Oral anticoagulants (OACs) are indicated for treatment and prevention of thromboembolic diseases. Supplemental patient education (education) has been proposed to improve outcomes, and this systematic review assesses the effect of education on mortality, thromboembolic events (TEEs) including venous thromboembolism (VTE), and bleeding in patients taking OACs. Randomized controlled trials were included, and 2 authors independently screened articles and assessed risk of bias. In 9 trials (controls, n = 720; intervention group patients, n = 646), 4 assessed critical outcomes of mortality, TEEs (VTE, stroke, and systemic embolism), and bleeding to estimate absolute risk ratios. When comparing education with usual care, in 1000 patients, there may be 12 fewer deaths (95% confidence interval [CI], 19 fewer to 154 more) and 16 fewer bleeding events (95% CI, 34 fewer to 135 more), but this evidence is uncertain; the evidence also suggests 6 fewer VTEs (95% CI, 10 fewer to 16 more) and 8 fewer TEEs (95% CI, 16 fewer to 18 more). The mean difference in time in therapeutic range may be 2.4% higher in the education group compared with usual care (95% CI, 2.79% lower to 7.58% higher). We also found very low certainty of evidence for a large increase in knowledge scores (standardized mean difference, 0.84 standard deviation units higher; 95% CI, 0.51-1.16). Overall, the certainty of evidence was low to very low because of serious risk of bias and serious imprecision. Additional sufficiently powered trials or different approaches to education are required to better assess supplemental education effects on outcomes in patients taking OACs.
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Bikdeli, Bavand, Renuka Visvanathan, David Jimenez, Manuel Monreal, Samuel Z. Goldhaber, and Behnood Bikdeli. "Use of Prophylaxis for Prevention of Venous Thromboembolism in Patients with Isolated Foot or Ankle Surgery: A Systematic Review and Meta-Analysis." Thrombosis and Haemostasis 119, no. 10 (August 20, 2019): 1686–94. http://dx.doi.org/10.1055/s-0039-1693464.
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AbstractAlthough prophylaxis for venous thromboembolism (VTE) is recommended after many surgeries, evidence base for use of VTE prophylaxis after foot or ankle surgery has been elusive, leading into varying guidelines recommendations and notable practice variations. We conducted a systematic review of the literature to determine if use of VTE prophylaxis decreased the frequency of subsequent VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE), compared with control. We searched PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through May 2018, for randomized controlled trials (RCTs) or prospective controlled observational studies of VTE prophylaxis in patients undergoing foot and ankle surgery. Our search retrieved 263 studies, of which 6 were finally included comprising 1,600 patients. Patients receiving VTE prophylaxis had lower risk for subsequent DVT (risk ratio [RR]: 0.72; 95% confidence interval [CI]: 0.55–0.94) and subsequent VTE (RR: 0.72; 95% CI: 0.55–0.94). There was only one case of nonfatal PE, no cases of fatal PE, and no change in all-cause mortality (RR: 3.51; 95% CI: 0.14–84.84). There was no significant difference in the risk for bleeding (RR: 2.12; 95% CI: 0.53–8.56). Very few RCTs exist regarding the efficacy and safety of VTE prophylaxis in foot and ankle surgery. Prophylaxis appears to reduce the risk of subsequent VTE, but the event rates are low and symptomatic events are rare. Future studies should determine the subgroups of patients undergoing foot or ankle surgery in whom prophylaxis may be most useful.
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Habibi Moghadam, Morteza, Marzieh Asadizaker, Simin Jahani, Elham Maraghi, Hakimeh Saadatifar, and Farhad Naanaei. "INVESTIGATING EFFECT OF NURSING INTERVENTIONS, BASED ON WELLS SCORE RESULTS, ON THE INCIDENCE OF DEEP VEIN THROMBOSIS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT." Asian Journal of Pharmaceutical and Clinical Research 11, no. 5 (May 1, 2018): 377. http://dx.doi.org/10.22159/ajpcr.2018.v11i5.24939.
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Objective: Venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complaint in critically ill patients. Therefore, the present study was conducted to determine the effect of nursing interventions, based on the Wells results, on the incidence of DVT in intensive care unit (ICU) patients.Methods: The present clinical trial was conducted on 72 ICU patients without DVT and PE who met the inclusion criteria according to Wells score in Dr. Ganjavian Hospital, Dezful in 2012. The participants were investigated and randomly divided into intervention (n=36) and control groups (n=36). The intervention group received preventive nursing measures based on the risk level determined by the Wells score, and routine therapeutic interventions were performed for the control group. Then, patients were evaluated using Wells score, D-dimer testing, and Doppler sonography on the 1st, 5th, and 10th days. Data were finally coded and entered into SPSS version 23. Data analysis was performed using Chi-square, Fisher’s exact, and Mann–Whitney U tests.Results: The incidence of DVT in both groups showed that 2 patients of the control group who were identified to be at risk using the Wells score were diagnosed with DVT while none of the patients of the intervention group experienced DVT. The present study showed that 22.2% of the patients of the control group suffered from non-pitting edema, which was significantly different from the intervention group (p=0.005).Conclusion: The results of the present study showed that using the Wells score for early identification of the at-risk patients and nursing interventions based on this score’s results is helpful in the prevention of DVT. Appropriate nursing interventions were also effective in reducing the incidence of non-pitting edema in the lower extremities.
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Halushko, O. A. "Complications of the infusion therapy and their prevention." Infusion & Chemotherapy, no. 3.2 (December 15, 2020): 45–47. http://dx.doi.org/10.32902/2663-0338-2020-3.2-45-47.
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Background. Infusion solutions are divided into several groups: crystalloids, colloids (natural and artificial), polyatomic alcohols, special drugs (infusion antibiotics, analgesics, hemostatics). Each solution type has its own complications.
Objective. To identify the main complications of infusions and prevention measures.
Materials and methods. Analysis of the available literature on this topic.
Results and discussion. After the transfusion of 1 liter of 0.9 % NaCl only 275 ml of this solution remains in plasma, and 725 ml passes into the interstitial space, causing edema. In addition, there is a risk of hyperchloraemic acidosis in case of massive transfusions. 0.9 % NaCl is inadequate in its ionic composition, has no reserve alkalinity, deepens hyperosmolar changes, so it is not used as monotherapy in daily practice. It is used as a solvent only. Ringer’s solution is also easily excreted into the interstitial space with the edema formation. It is hyperosmolar, contains a large number of chlorine ions and is excreted by the kidneys, so it should be used with caution in patients with kidney disease. A number of drugs (aminocaproic acid, amphotericin B, blood products, sodium thiopental) are incompatible with Ringer’s solution and Ringer’s lactate. In turn, 5 % glucose solution is ineffective for detoxification, liver cirrhosis and restoring the circulating blood volume in case of blood loss. Glucose infusions can increase the production of carbon dioxide and lactate, increase ischemic damage to the brain and other organs, and promote tissue edema. At present, the routine use of glucose during surgery and in critically ill patients has been completely abandoned. Preparations of polyatomic alcohols can be divided into the preparations of six-atomic alcohols – mannitol (Mannit) and sorbitol (Sorbilact, Reosorbilact) and five-atomic alcohols (xylitol – Xylate, Gluxyl, Lactoxyl) (all of the listed solutions are made by “Yuria-Pharm”). Side effects of mannitol include tachycardia, thrombophlebitis, chest pain, skin rash, dehydration, dyspepsia, fluid and electrolyte balance, and hallucinations. Hypotension is the most common complication of mannitol usage. Reosorbilact is a modern balanced infusion solution. Its effects include the hypovolemia correction, restoration of electrolyte disturbances, normalization of cardiac activity and nerve conduction, increase of alkaline blood reserve and restoration of energy balance. In case of the significant overdose Reosorbilact can cause alkalosis. Contraindications to its administration include alkalosis, cerebral hemorrhage, pulmonary embolism, and 3 grade hypertension. Xylitol is a five-atom alcohol that is rapidly incorporated into the pentose phosphate metaboliс pathway. Its side effects include the allergic reactions, hypertension, nausea, and lactic acidosis. The main disadvantage of hydroxyethyl starch (HES) drugs is the adverse effect on hemostasis (especially in drugs of the first generation). In addition, HES may impair the renal function, so they should be used in the lowest effective dose for the shortest period of time. In addition to complications associated with infusion solutions, there are complications associated with the injection procedure (hematoma, infiltration, thromboembolism, air embolism, and phlebitis). The thorough monitoring is needed to prevent the complications of all stages of infusion therapy. Such parameters as blood pressure, heart rate, blood gas composition, capillary filling time, mental status, and diuresis should be monitored. It is also necessary to carefully examine the composition of prescribed drugs and instructions for their medical use, to control the infusion rate, and to combine different drugs rationally.
Conclusions. 1. There are several classes of infusion solutions, and each of them has its own advantages and disadvantages. 2. Reosorbilact is a balanced drug with the minimal risk of side effects. 3. To prevent complications, it is necessary to monitor the basic physiological parameters, to control the infusion rate, and to rationally combine different tools.
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Alameri, Mariam A., Syed A. Syed Sulaiman, Abdullah M. Ashour, and Ma’ad F. Al-Saati. "Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial." Pharmacy Practice 18, no. 3 (September 22, 2020): 2025. http://dx.doi.org/10.18549/pharmpract.2020.3.2025.
Full textAbstract:
Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE).
Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs.
Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation.
Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05).
Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery.
Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.
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Sheu, Joen-Rong, Seh-Huang Chao, Mao-Hsiung Yen, and Tur-Fu Huang. "In Vivo Antithrombotic Effect of Triflavin, an Arg-Gly-Asp Containing Peptide on Platelet Plug Formation in Mesenteric Microvessels of Mice." Thrombosis and Haemostasis 72, no. 04 (1994): 617–21. http://dx.doi.org/10.1055/s-0038-1648924.
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SummaryTriflavin, an Arg-Gly-Asp-containing snake venom peptide, inhibits platelet aggregation through the blockade of fibrinogen binding to the activated platelets. In this study, platelet thrombus formation was induced by irradiation of the mesenteric venules with filtered light in mice pretreated intravenously with fluorescein sodium. Electron microscopy reveals moderately damaged endothelial cells, as well as aggregates consisting almost exclusively of platelets with pseudopod formation, and degranulated appearance. Triflavin (10-20 µg/g) significantly prolonged the lag period of inducing platelet plug formation in mesenteric venules when it was intravenously infused. Triflavin (20 µg/g) prolonged the occlusion time about 2-fold (from control 112 ± 23 to 240 ± 47 s). Furthermore, PGE, briefly prolonged the occlusion time about 1.5-fold (from 105 ± 21 to 168 ± 20 s) when it was given by continuous infusion (40 µg/kg/min). On the other hand, triflavin was also effective in reducing the mortality of ADP-induced acute pulmonary thromboembolism in mice when administered intravenously at dose of 2-4 µg/g. Heparin (1.5 U/g) and indomethacin (200 µg/g) had no significant effect in prolonging the occlusion time or in reducing ADP-induced pulmonary embolism in mice. Therefore, triflavin is an effective antithrombotic agent in preventing the thromboembolism in these two in vivo models.
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Goldhaber, Samuel. "Venous Thromboembolism Prophylaxis in Medical Patients." Thrombosis and Haemostasis 82, no. 08 (1999): 899–901. http://dx.doi.org/10.1055/s-0037-1615929.
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IntroductionPharmacologic measures to prevent venous thromboembolism were first routinely incorporated into the practice of general surgeons, urologists, and orthopedic surgeons in 1975, after the landmark International Multicentre Trial was published.1 This randomized trial allocated 4,121 surgical patients either to unfractionated heparin 5,000 U, beginning 2 hours preoperatively and continuing every 8 hours for 7 days, or to no heparin. Among the heparin-treated group, two patients had massive pulmonary embolism (PE) verified upon autopsy, compared with 16 among the no heparin group.These dramatic differences were reinforced by a subsequent meta-analysis of 15,598 surgical patients in randomized trials of venous thromboembolism prevention with low fixed dose (“minidose”) heparin.2 Those assigned to heparin prophylaxis had a two-thirds reduction in predominantly asymptomatic deep vein thrombosis (DVT), a one-third reduction in nonfatal pulmonary embolism, and a marked reduction in fatal PE (19 in heparin patients compared with 55 among controls). Based upon the results of these studies, unfractionated heparin in a dose of 5,000 U twice or three times daily, beginning 2 hours preoperatively, became the standard pharmacologic approach to perioperative prevention of DVT and PE.Despite the intensive study of venous thromboembolism in thousands of surgical patients, the investigation of DVT and PE developing as a complication among medical patients hospitalized for other primary conditions has languished, except for in stroke and myocardial infarction patients. Several fundamental issues are apparent. First, the incidence of venous thromboembolism among hospitalized patients has not been precisely elucidated. Second, subsets of patients with potentially the greatest risk, such as those in medical intensive care units, warrant special attention. Third, the failure rates of conventional low-dose heparin prophylaxis and mechanical prophylaxis with intermittent pneumatic compression boots have not been adequately defined among contemporary hospitalized medical patients. Fourth, the Food and Drug Administration has not approved low molecular weight heparin (LMWH) for prophylaxis against venous thromboembolism in medical patients. Such approval awaits the design, execution, and analysis of appropriate clinical trials in this understudied population.An Israeli study undertaken more than two decades ago provided intriguing evidence to support the concept that mortality reduction could be achieved in hospitalized general medical patients with low-dose heparin prophylaxis.3 This hypothesis was tested in 1,358 consecutive patients greater than 40 years of age who were admitted through the emergency department to the medical wards of an acute care hospital. Eligible patients with even numbered hospital records were assigned to receive 5,000 U low-dose heparin twice daily. Those with odd numbered records served as controls. Among patients allocated to heparin, there was a 31% reduction in mortality from 10.9% in the control group to 7.8% in the heparin group. The reduction in mortality in the heparin-treated group was evident from the first day, and the difference increased significantly and consistently with time until the end of the study period. Because the death rate was highest in the first 2 days in both groups, the reduction in mortality in absolute numbers was greatest on those 2 days. However, the relative mortality reduction remained stable throughout the study period.While low-dose heparin was demonstrated in the 1970s to be effective and safe for the prevention of venous thromboembolism in many thousands of surgical patients, only miniscule studies were carried out among medical patients during that era. For example, the Royal Infirmary in Glasgow studied 100 medical patients hospitalized with heart failure or chest infection.4 Patients were randomized to receive either heparin 5,000 U every 8 hours or to receive no specific prophylaxis measures. The diagnosis of DVT was established by iodine-125 fibrinogen leg scanning, which was undertaken in all study patients within 24 hours of hospitalization and repeated every other day for 14 days or until hospital discharge. The results in this group of hospitalized medical patients were dramatic. Among controls, 26% developed DVT, whereas the rate was only 4% among those receiving low-dose heparin.In a trial in 1986 that focused on octogenarian medical inpatients, a placebo-controlled, randomized, double-blind study5 utilized a once daily low molecular weight heparin (Pharmuka 10169, subsequently renamed enoxaparin). The dose was 60 mg injected subcutaneously once daily. The potential development of DVT was assessed by iodine-125 fibrinogen leg scanning in all patients. The trial lasted 10 days, and 270 patients were enrolled. The majority of subjects suffered from heart failure, respiratory diseases, stroke, or cancer. Of 263 evaluable patients, 9% in the placebo group developed DVT, compared with 3% of those receiving LMWH prophylaxis. Except for injection site hematomas, bleeding complications were not appreciably increased in the LMWH group.A trial involving 11,693 medical patients with infectious diseases randomized patients to receive either 5,000 U of heparin every 12 hours or no prophylaxis.6 Although patients were treated for a maximum of 3 weeks, follow-up was carried out for a maximum of 2 months. Heparin prophylaxis delayed the occurrence of fatal PE from a median of 12 days to a median of 28 days. Far more nonfatal thromboembolic complications in the control group (116 vs. 70, p = 0.0012). However, the prespecified primary endpoint was clinically relevant, autopsy-verified PE. In this respect, there was virtually no difference between the two groups: 15 heparin treated and 16 control group patients had autopsy-verified fatal PEs. This large trial, which yielded disappointing results, may have been flawed had the following study design flaws: 1) a lack of statistical power to detect a difference between the two groups in the primary endpoint, 2) the restriction of heparin prophylaxis to 3 weeks, and 3) an inadequate dose of heparin. (Keep in mind that the International Multicentre trial1 used low-dose heparin every 8 hours, not every 12 hours.)In the past decade, low molecular weight heparin has supplanted unfractionated heparin for prophylaxis against venous thromboembolism in total hip replacement7 and has proved superior both to warfarin8,9 and to graduated compression stockings10 for total knee replacement. This does not necessarily mean, however, that low molecular weight heparin will prove superior to unfractionated heparin, warfarin, or graduated compression stockings for prophylaxis of hospitalized medical patients.The MEDENOX trial of enoxaparin prophylaxis in medical patients completed enrollment of approximately 1,100 subjects in July 1998. Patients were randomized to one of three groups in a double-blind controlled trial: enoxaparin 20 mg once daily, enoxaparin 40 mg once daily, or placebo. The principal endpoint is the incidence of DVT as assessed by contrast venography on approximately day 10 of hospitalization. The results of this crucially important trial which favored enoxaparin 40 mg once daily, will be presented at the August 1999 XVII Congress of the International Society on Thrombosis and Haemostasis.Also, the Veterans Affairs Cooperative Studies Program has organized a randomized trial to study the effect of low-dose heparin prophylaxis on mortality among hospitalized general medical patients.11 Results will be available in about 5 years.Intermittent pneumatic compression devices constitute an alternative, nonpharmacologic approach to prevent PE and DVT. Though effective, special care must be taken to ensure that these devices are worn as prescribed.12 Frequent removal and nonuse can be problematic, especially in patients outside of an intensive care unit. In addition to the mechanical effect of increasing venous blood flow in the legs, these devices appear to cause an increase in endogenous fibrinolysis, due to stimulation of the vascular endothelial wall.13-15 It is possible that for hospitalized medical patients, combined mechanical and pharmacologic prophylaxis will find a special niche. For example, in certain surgical subspecialties, combined prophylaxis modalities are routinely used. Urologists combine intermittent pneumatic compression boots and adjusted-dose warfarin following radical prostatectomy.16 Neurosurgeons employ compression boots plus fixed, low-dose heparin in craniotomy patients with malignancies.17 The medical intensive care unit setting remains one of the last frontiers where the culture of routine venous thromboembolism prophylaxis is not well developed. Prophylaxis should be part of the standard admission orders, just like H2-blockers or carafate are almost always ordered routinely to prevent stress ulcers. Intensive care unit patients pose special challenges when planning prophylaxis strategies. First, these patients are often bleeding overtly or are admitted with thrombocytopenia. Accordingly, heparin or warfarin are often contraindicated. Second, leg ulcers, wounds, or peripheral arterial occlusive disease will preclude the use of intermittent pneumatic compression devices. With these problems in mind, it is useful to examine the current state of prophylaxis among intensive care unit patients.In 1994, the Venous Thromboembolism Research Group at Brigham and Women’s Hospital found that only one-third of consecutive patients admitted to the Medical Intensive Care Unit received prophylaxis against PE and DVT.18 In a subsequent survey of this population, one-third of patients developed DVT, and half of these were proximal leg DVTs. Overall, 56% received prophylaxis.19 Surprisingly, prophylaxis appeared to have little impact on DVT rates. The overall DVT rate in patients who had received either heparin or pneumatic compression prophylaxis was 34%, compared with 32% in patients who did not receive any prophylaxis. This observation should be interpreted cautiously because these patients were not randomly allocated to prophylaxis.There is currently no consensus on optimal prophylaxis for medical intensive care unit patients.20 Two prior trials have failed to show the superiority of low molecular weight heparin compared with unfractionated low-dose heparin among hospitalized medical patients.21,22 These two trials may have administered subtherapeutic doses of LMWH.We have just completed a multicenter, randomized, controlled trial of heparin 5,000 U twice daily (“miniheparin”) versus enoxaparin 30 mg twice daily among Medical Intensive Care Unit patients. This multicentered study has the principal endpoint of venous thrombosis proven by ultrasound examination. Approximately, almost 300 patients have been enrolled. We expect to present the results of this trial at the August 1999 XVII Congress of the International Society on Thrombosis and Haemostasis.
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Yogendrakumar, Vignan, Ronda Lun, Brian Hutton, Dean A. Fergusson, and Dar Dowlatshahi. "Comparing pharmacological venous thromboembolism prophylaxis to intermittent pneumatic compression in acute intracerebral haemorrhage: protocol for a systematic review and network meta-analysis." BMJ Open 8, no. 11 (November 2018): e024405. http://dx.doi.org/10.1136/bmjopen-2018-024405.
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IntroductionPatients with an intracerebral haemorrhage are at increased risk of venous thromboembolism. Pharmacotherapy and pneumatic compression devices are capable of preventing venous thromboembolism, however both interventions have limitations. There are no head-to-head comparisons between these two interventions. To address this knowledge gap, we plan to perform a systematic review and network meta-analysis to examine the comparative effectiveness of pharmacological prophylaxis and mechanical compression devices in the context of intracerebral haemorrhage.Methods and analysisMEDLINE, PUBMED, EMBASE, CENTRAL, ClinicalTrials.gov and the Internet Stroke Trials Registry will be searched with assistance from an experienced information specialist. Eligible studies will include those that have enrolled adults presenting with spontaneous intracerebral haemorrhage and compared one or more of the respective interventions against each other and/or a control. Primary outcomes to be assessed are occurrence of new venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) and haematoma expansion, defined as a significant enlargement of baseline haemorrhage or new haemorrhage occurrence. Both randomised and non-randomised comparative studies will be included. Data on participant characteristics, study design, intervention details and outcomes will be extracted. Study quality will be assessed using the Cochrane Risk of Bias Tool and the Robins-I tool. Bayesian network meta-analyses will be performed to compare interventions based on all available direct and indirect evidence. If the transitivity assumption for network meta-analysis cannot be met, we will perform a qualitative assessment.Ethics and disseminationFormal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through conference presentations, and peer-reviewed publications. In an area of clinical practice where equipoise exists, the findings of this study may assist in determining which treatment intervention is most effective in venous thromboembolism prevention.PROSPERO registration numberCRD42018090960.
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Ageno, Walter. "Arterial and Venous Thrombosis: Clinical Evidence for Mechanistic Overlap." Blood 124, no. 21 (December 6, 2014): SCI—3—SCI—3. http://dx.doi.org/10.1182/blood.v124.21.sci-3.sci-3.
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Abstract Venous and arterial thromboembolic disorders are usually considered as two separate pathophysiological entities. Over the last years, some clinical evidence challenged this common view. First of all, a number of studies have reported an increased risk of subsequent symptomatic atherothrombosis in patients with venous thromboembolism (VTE), in particular after unprovoked events. In a substudy of the Warfarin optimal duration Italian pulmonary embolism (WODIT PE) trial, the incidence of arterial cardiovascular events in patients affected by unprovoked pulmonary embolism (PE) was significantly higher than in patients with PE secondary to transient risk factors such as surgery, trauma or immobilization. This finding was subsequently confirmed by the results of a large prospective cohort study comparing the incidence of symptomatic atherosclerotic disease in patients with unprovoked VTE and patients with secondary VTE. In a subsequent population-based cohort study from Denmark, the relative risk of cardiovascular events in the first year after deep vein thrombosis (DVT) and after PE was significantly higher than in a control population and remained increased during the subsequent 20 years of follow-up. The results of these and other studies were summarized in a meta-analysis of the literature that confirmed a significantly higher incidence rate ratio of arterial cardiovascular events in patients with unprovoked VTE than in patients with provoked VTE and in controls. A possible explanation for such association between unprovoked VTE and arterial thrombosis could be represented by shared risk factors between these disease entities. Among traditional cardiovascular risk factors, obesity and age have consistently been demonstrated to be independent risk factors also for VTE. Of interest, obesity was also shown to be associated with a significantly increased risk of recurrent VTE. Obesity, and in particular visceral adiposity (abdominal obesity), predisposes to inflammatory and hypercoagulable states thus resulting in a prothrombotic condition that may cause both venous and arterial thrombotic events. A study from Norway found abdominal obesity defined by the measurement of waist circumference to be a better predictor of the risk of VTE than obesity defined by the body mass index. In addition, abdominal obesity is commonly associated with the presence of arterial hypertension, diabetes mellitus, and dyslipidemia. In a meta-analysis of studies on the association between cardiovascular risk factors and VTE, we found all these major arterial risk factors to be significantly associated with venous thrombosis. In addition, we and others found an association between the metabolic syndrome, which is a cluster of cardiovascular risk factors, and VTE. Finally, a large-population based case-control study reported an increased risk of venous thrombosis in both current and ex-smokers compared to those who had never smoked. Although these associations were not fully confirmed by the results of prospective cohort studies, and although the strength of the association was not comparable to that reported for major traditional risk factors for venous thrombosis, these findings may be clinically relevant because cardiovascular risk factors are common, they frequently co-exist, and their co-existence may result in an additive effect. Moreover, most cardiovascular risk factors are modifiable. These observations also raised the question of whether drugs that are effective in preventing arterial thrombosis, such as aspirin and statins, may be also effective for the prevention of venous thrombosis. Two recent randomized controlled trials compared aspirin with placebo for the secondary prevention of VTE after an initial course of anticoagulant therapy. When the results of these two studies were pooled together, there was a statistically significant 32% reduction in the rate of VTE recurrence with no increased risk of major bleeding. In a meta-analysis, we found that statins reduce the risk of a first VTE event by 20%. Other studies have suggested that statins may also play a role in the secondary prevention of VTE, but no randomized controlled trials are available to support this hypothesis. In conclusion, the presence of cardiovascular risk factors should be carefully assessed in patients with unprovoked VTE and their management may concomitantly prevent subsequent atherothrombotic events and reduce the risk of recurrent VTE. Future studies should assess whether the combination of aspirin and statins may result in a substantial reduction of the risk of recurrent VTE. Disclosures Ageno: Bayer Healthcare: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer Ingelheim: Honoraria, Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Honoraria; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; STAGO: Honoraria. Off Label Use: I will discuss evidences on the role of aspirin and statins for the prevention of venous thromboembolism.
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Landi, Daniel, Michele G. Beckman, Nirmish R. Shah, Paula Bockenstedt, Althea M. Grant, John A. Heit, Nigel S. Key, et al. "Characteristics of abdominal vein thrombosis in children and adults." Thrombosis and Haemostasis 109, no. 04 (2013): 625–32. http://dx.doi.org/10.1160/th12-08-0568.
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SummaryThe demographic and clinical characteristics of adults and children with lower extremity deep-vein thrombosis and/or pulmonary embolism (LE DVT/PE) may differ from those with abdominal vein thrombosis (abdominal VT). Abdominal VT can be a presenting sign of an underlying prothrombotic state, and its presence in the setting of known disease might have prognostic implications different from LE DVT/PE. This study describes clinical presentations of abdominal VT compared to LE DVT/PE in adults and children. We analysed prospec-tively-collected data from consecutive consenting patients enrolled in one of seven Centers for Disease Control and Prevention (CDC) funded Thrombosis and Hemostasis Network Centers from August 2003 to April 2011 to compare the demographic and clinical characteristics of adults and children with abdominal VT. Both adults and children with abdominal VT tended to be younger and have a lower body mass index (BMI) than those with LE DVT/PE. Of patients with abdominal V T, children were more likely to have inferior vena cava (IVC) thrombosis than adults. For adults with venous thromboembolism (VTE), relatively more women had abdominal VT than LE DVT/PE, while the proportions with LE DVT/PE and abdominal VT by sex were similar in children. Children with abdominal VT were more likely to have diagnosed inherited thrombophilia, while trauma was more common in children with LE DVT/PE. In conclusion, both children and adults with abdominal VT were younger with a lower BMI than those with LE DVT/ PE. Significant differences exist between children and adults in respect to abdominal VT compared to LE DVT/PE.Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
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Thanh Toan, Vo, To Dong Kha, and Bui Van Anh. "Evaluating the effectiveness of using enoxaparin to prevent venous thromboembolism in hip replacement patients: A retrospective cohort study." Biomedical Research and Therapy 8, no. 2 (February 28, 2021): 4228–32. http://dx.doi.org/10.15419/bmrat.v8i2.661.
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Introduction: Our research aims to evaluate the effectiveness of thromboprophylaxis using enoxaparin in patients undergoing hip replacement.
Methods: A retrospective cohort study was conducted based on medical records of patients aged 40 years and older undergoing hip replacement. Exclusion criteria included patients who had used anticoagulants to prevent other diseases, patients with a history of chronic renal failure, liver failure, cancer or allergy to anticoagulants, and patients with indicated mechanical prophylaxis. In our study, 65 patients were randomized into 2 groups - the control group and the venous thromboembolism (VTE) prophylaxis group (receiving subcutaneous enoxaparin 40 mg daily for 7 - 14 days). Preventive effectiveness was evaluated based on the comparison of VTE incidence after surgery between the groups.
Results: In our study, most of the patients were over 60 years old (79.2%). No case of pulmonary embolism was recorded. There were 11 patients in the control group (17.2%) who developed deep venous thrombosis (DVT) versus 2 patients in the prophylaxis group (3.1%). After adjusting for postoperative hospital stay, use of enoxaparin reduced the risk of DVT by 89.7% (OR 0.103, 95% confidence interval 0.019-0.569, p=0.009), especially in patients over 60 years old (OR 0.147, 95% confidence interval 0.026 - 0.822, p = 0.029).
Conclusion: This study demonstrates that using enoxaparin significantly reduces the incidence of DVT in patients undergoing hip replacement, especially in patients over 60 years old.
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Jiang, Bo, Qasim Malik, and Louis Romel Crevecoeur. "Use Of Novel Oral Anticoagulants For Treatment Of Venous Thromboembolism (VTE) In Patients With Malignancy: Meta-Analysis Of Randomized Controlled Trials." Blood 122, no. 21 (November 15, 2013): 1150. http://dx.doi.org/10.1182/blood.v122.21.1150.1150.
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Abstract Use of Novel oral anticoagulants for treatment of venous thromboembolism (VTE) in patients with malignancy: meta-analysis of randomized controlled trials Background Venous thromboembolism (VTE) is a frequent complication of cancers. Patients with cancer have at least a 6 fold increased risk for VTE compared to those without cancer, and the diagnosis of VTE in cancer patient is associated with a 2-4 fold decreased survival during the first year. The mainstays of anticoagulant treatment in cancer patients remain unfractionated heparin, LMWH, and the Vitamin K antagonists (VKAs), with current guideline favoring the use of LMWH. Novel oral anticoagulants (NOAs) that directly inhibit factor Xa and thrombin, including dabigatran, rivaroxaban, and apixaban, represents a milestone in the prevention and treatment of VTE. However, there have been no clinical trials to test the efficacy of NOAs in cancer patients, therefore, use of these agents in cancer population is an extrapolation of published results with general population. Objectives Determine the efficacy of novel oral anticoagulants (thrombin inhibitor; dabigatran, and direct factor Xa inhibitors; rivaroxaban and apixaban) in VTE treatment in patients with cancer. Data source A systematic review was conducted using MEDLINE and EMBASE up to July 2013. Key words used included venous thromboembolism, pulmonary embolism, deep venous thrombosis, cancer, dabigatran, rivaroxaban, and apixaban. Due to the fact that no randomized controlled trials (RCTs) in cancer population, we combined data that were extracted from major RCTs that include cancer patients and performed a sub-group analysis. Results Three randomized controlled trials (RCTs) were reviewed, and a total of 550 patients with cancers were analyzed. NOAs are not inferior to the current standard anticoagulant therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist, to prevent symptomatic recurrent venous thromboembolism. Odd ratio (OR) is 0.988 (95% CI, 0.51-1.94). There is no significant heterogeneity. The major bleeding events were not analyzed due to lack of sub-group data in the trials. Conclusion Cancer patients have different hemodynamics and unique features that make the treatment of VTE challenging. These includes: tumor-associated pro-coagulant, venous stasis and endothelial damage from chemotherapy and catheters, an increased risk of anticoagulant-related bleeding, and the complexity of anticoagulant control because of the occurrence of urgent procedures. The development of NOAs provided new modalities to treat VTEs in cancer patients, as it showed that NOAs is non-inferior to the current standard anticoagulant therapy. However, large scale randomized controlled trials specifically targeted cancer patients are needed. Disclosures: No relevant conflicts of interest to declare.
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Spyropoulos, Alex, Mohamed Hussein, Jay Lin, and David Battleman. "Rates of Venous Thromboembolism in Commercially Insured US Surgical Patients." Blood 112, no. 11 (November 16, 2008): 526. http://dx.doi.org/10.1182/blood.v112.11.526.526.
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Abstract Introduction: Venous thromboembolism (VTE) constitutes a major healthcare burden in the United States (US), despite being effectively prevented by VTE prophylaxis. However, many patients at risk for VTE receive inadequate prophylaxis, and this has prompted the development of national performance measures to help improve prescribing practices. This study investigates the rates of post-operative VTE prevention in a real-world population of commercially-insured US surgical patients, and identifies VTE risk factors in this group. Methods: Discharges from the PharMetrics database (January 2001–December 2005) that had ICD-9 codes for orthopedic or abdominal surgery and were aged ≥18 years were included in the study. Patients aged ≥65 years and not in a Medicare Risk group and those without complete records or health plan coverage were excluded. The primary outcome measure for this study was the rate of (and time to) symptomatic VTE following surgery (as identified by ICD-9 codes), and the secondary outcome measure was the identification of independent VTE risk factors using logistic regression analysis to control for patient and hospital characteristics. Results: 172,320 discharges met the study criteria, of which 23.9% underwent orthopedic surgery and 76.1% underwent abdominal surgery. Primary outcome measures are shown in Table 1. In summary, orthopedic discharges had a higher incidence of clinically symptomatic VTE (4.7%) than abdominal discharges (3.1%). Both types of surgery had a similar distribution of VTE into deep-vein thrombosis (DVT, 72.5–75.0% of all VTE respectively), pulmonary embolism (PE, 22.5–25.0% of all VTE respectively), or both DVT and PE (2.5% of all VTE). The median time to a VTE event was shorter in orthopedic discharges (median 30 days) than their abdominal surgery counterparts (median 65 days). When considering all discharges in a logistic regression analysis, a prior history of VTE was found to be the strongest independent predictor of VTE (odds ratio [OR] 10.2; 95% confidence interval [CI] 9.2–11.4; p<0.001). Other significant variables associated with VTE outcomes included orthopedic surgery rather than abdominal surgery (OR 1.4; 95% CI 1.4–1.6), increasing age (per year) (OR 1.02; 95% CI 1.01–1.02), male gender (OR 1.18; 95% CI 1.09–1.28), increasing index hospitalization length of stay (per day) (OR 1.06; 95% CI 1.05–1.06), and pre-index Charlson comorbidity index (OR 1.12; 95% CI 1.09–1.14). Conclusions: Many patients undergoing orthopedic or abdominal surgery are at risk for VTE, with approximately 1 in 25 patients in this analysis experiencing a clinical VTE event. Improved implementation of national performance measures may help reduce the overall burden of VTE in the United States. Table 1 – VTE event rates Total (N=172,320) Orthopedic Surgery (N=41,139) Abdominal Surgery (N=131,181) Event, n (%) VTE 5956 (3.5) 1944 (4.7) 4012 (3.1) DVT 4367 (2.5) 1458 (3.5) 2909 (2.2) PE 1439 (0.8) 438 (1.1) 1001(0.8) DVT + PE 150 (0.1) 48 (0.1) 102 (0.1) Time to VTE Event: (days, median) VTE 51 30 65 DVT 70 34 83 PE 46 20 26 DVT+PE 31 17 27.5
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Aviña-Zubieta, J. Antonio, Michael Jansz, Eric C. Sayre, and Hyon K. Choi. "The Risk of Deep Venous Thrombosis and Pulmonary Embolism in Primary Sjögren Syndrome: A General Population-based Study." Journal of Rheumatology 44, no. 8 (March 15, 2017): 1184–89. http://dx.doi.org/10.3899/jrheum.160185.
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Objective.To estimate the future risk and time trends of venous thromboembolism (VTE) in individuals with newly diagnosed primary Sjögren syndrome (pSS) in the general population.Methods.Using a population database that includes all residents of British Columbia, Canada, we created a study cohort of all patients with incident SS and up to 10 controls from the general population matched for age, sex, and entry time. We compared incidence rates (IR) of pulmonary embolism (PE), deep vein thrombosis (DVT), and VTE between the 2 groups according to SS disease duration. We calculated HR, adjusting for confounders.Results.Among 1175 incident pSS cases (mean age 56.7 yrs, 87.6% women), the IR of PE, DVT, and VTE were 3.9, 2.8, and 5.2 per 1000 person-years (PY), respectively; the corresponding rates in the comparison cohort were 0.9, 0.8, and 1.4 per 1000 PY. Compared with non-SS individuals, the multivariable HR for PE, DVT, and VTE among SS cases were 4.07 (95% CI 2.04–8.09), 2.80 (95% CI 1.27–6.17), and 2.92 (95% CI 1.66–5.16), respectively. The HR matched for age, sex, and entry time for VTE, PE, and DVT were highest during the first year after SS diagnosis (8.29, 95% CI 2.57–26.77; 4.72, 95% CI 1.13–19.73; and 7.34, 95% CI 2.80–19.25, respectively).Conclusion.These findings provide population-based evidence that patients with pSS have a substantially increased risk of VTE, especially within the first year after SS diagnosis. Further research into the involvement of monitoring and prevention of VTE in SS may be warranted.
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Cohen, Alexander Thomas, Theodore Erich Spiro, Harry Roger Büller, Lloyd Haskell, Da-Yi Hu, Russell Hull, Alexandre Mebazaa, et al. "Rivaroxaban Compared with Enoxaparin for the Prevention of Venous Thromboembolism In Acutely Ill Medical Patients: MAGELLAN Study Methodology." Blood 116, no. 21 (November 19, 2010): 3331. http://dx.doi.org/10.1182/blood.v116.21.3331.3331.
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Abstract Abstract 3331 Background: The results of clinical trials comparing low molecular weight heparins or a pentasaccharide with placebo controls have provided compelling evidence for the benefits of pharmacologic thromboprophylaxis for 10–14 days in acutely ill medical patients (Samama et al. N Engl J Med 1999;341:793–800; Leizorovicz et al. Circulation 2004;110:874–879; Cohen et al. BMJ 2006;332:325–329). Oral rivaroxaban 10 mg once daily (od) has been shown to be effective and well tolerated for the prevention of venous thromboembolism (VTE) for 31–39 days after elective hip replacement (Eriksson et al. N Engl J Med 2008;358:2765–2775; Kakkar et al. Lancet 2008;372:31–39) and for 10–14 days after knee replacement surgery in adult patients (Lassen et al. N Engl J Med 2008;358:2776–2786; Turpie et al. Lancet 2009;373:1673–1680). Aims: To compare the efficacy and safety of thromboprophylaxis with oral rivaroxaban 10 mg od for (1) up to 14 days and (2) up to 39 days with subcutaneous enoxaparin 40 mg od for up to 14 days in patients with acute medical illness requiring hospitalization. Methods: MAGELLAN (Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized acutely iLL medical patients comparing rivaroxabAN with enoxaparin) was a multinational, multicenter, randomized, double-blind, double-dummy, active comparator controlled study in patients with current reduced mobility that was likely to persist. All enrolled patients received study medication on day 1 (defined as the day of randomization), underwent mandatory bilateral lower limb venous ultrasonography on day 10±4 and on day 35±4, and were followed until day 90±7. Suspected symptomatic VTE was investigated promptly using appropriate vascular and pulmonary imaging procedures. The inclusion criteria were: age ≥40 years; immobilization; heart failure, active cancer, acute ischemic stroke, acute infection, acute inflammatory or rheumatic disorders, or acute respiratory insufficiency. Patients with acute ischemic stroke without leg paresis or paralysis, acute infection, acute inflammatory or rheumatic disorders, or acute respiratory insufficiency required at least 1 additional risk factor for VTE, e.g. age ≥75 years, previous VTE, previous cancer or heart failure, severe venous disease, thrombophilia, recent major surgery or serious trauma, hormone replacement therapy or morbid obesity (body mass index ≥35 kg/m2). The exclusion criteria included an increased risk of bleeding; prohibited drugs or procedures, e.g. anticoagulant therapy; and concomitant conditions or diseases, e.g. allergies, severe renal or liver disease. The primary efficacy outcome was the composite of asymptomatic proximal deep vein thrombosis (DVT) detected by mandatory venous ultrasonography, symptomatic proximal and distal DVT, symptomatic pulmonary embolism, and fatal VTE reported during the treatment phase of the study. There were 2 efficacy analysis populations, pertaining to the 2 primary efficacy endpoints. The study was powered at the 90% level to show non-inferiority at day 10±4 and superiority at day 35±4. The primary safety outcome was the composite of major bleeding events and clinically relevant non-major bleeding events. Sparse pharmacokinetic/pharmacodynamic sampling was performed by measuring rivaroxaban levels at peak and trough time points in all patients. In selected centers, a full pharmacokinetic/pharmacodynamic profile was performed. Pharmacogenetic and health economic outcomes were also assessed. Results: The first patient was enrolled in December 2007. As of July 2010, 8,101 subjects have been enrolled in the study from 556 centers in 52 countries. The mean age of patients is approximately 69 years, and around 46% are female. Approximate distributions of the acute medical conditions are as follows: 34% have heart failure, 32% have acute infectious diseases, 24% have acute respiratory insufficiency, 17% have acute ischemic stroke, 8% have active cancer, and 5% have acute inflammatory and rheumatic diseases. Conclusions: MAGELLAN will determine the efficacy and safety of oral rivaroxaban (short- and extended-duration regimens) compared with the current standard of care in a diverse population of acutely ill medical patients with reduced mobility and other risk factors for venous thromboembolic disease. Disclosures: Cohen: Bayer Schering Pharma: Consultancy, Research Funding; Johnson and Johnson: Consultancy, Research Funding. Spiro:Bayer Healthcare Pharmaceuticals Inc.: Employment. Büller:Bayer Schering Pharma: Consultancy, Research Funding. Haskell:Johnson & Johnson Pharmaceutical Research & Development L.L.C.: Employment. Hu:Bayer Schering Pharma: Research Funding. Hull:Bayer Schering Pharma: Research Funding. Mebazaa:Bayer Schering Pharma: Research Funding. Merli:Bayer Schering Pharma: Research Funding. Schellong:Bayer Schering Pharma: Research Funding. Spyropoulos:Bayer Schering Pharma: Research Funding. Tapson:Bayer Schering Pharma: Research Funding.
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Lauw, Mandy N., Bronno Van der Holt, Saskia Middeldorp, Joost CM Meijers, and Bart J. Biemond. "Impact of Prophylactic Fresh Frozen Plasma On Venous Thromboembolism in Adults Treated for Acute Lymphoblastic Leukemia Receiving Asparaginase,." Blood 118, no. 21 (November 18, 2011): 3345. http://dx.doi.org/10.1182/blood.v118.21.3345.3345.
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Abstract Abstract 3345 Background: Acute lymphoblastic leukemia (ALL) is frequently complicated by venous thromboembolism (VTE). The reported incidence varies from 2% to 37%, with the highest risk arising in the first weeks after treatment initiation. VTE leads to morbidity, mortality and premature termination of therapy. Prevention of VTE in ALL is complicated, as thrombotic and bleeding factors need to be balanced. The efficacy of prophylactic antithrombotic measures is not clear yet, and standardized guidelines are lacking. We assessed the effect of various prevention protocols on the VTE risk in adults treated for ALL. Methods: Between April 1999 and November 2005, 240 consecutive patients aged 16–59 years with newly diagnosed ALL were treated with the same anti-leukemic protocol in a Dutch-Belgian multicenter study, which included L-asparaginase in cycle 1 (5000 U/m2/day, day 15–28). All VTE events during treatment were prospectively recorded. VTE prophylaxis was applied only in cycle 1 during asparaginase administration, and varied between different centers: no prophylaxis, fresh frozen plasma (FFP), or antithrombin (AT) concentrate. A centers' prevention protocol was used as a proxy for all patients treated in that center. AT plasma levels were assessed of patients with VTE and 22 controls without VTE. We determined VTE incidence in cycle 1, the impact of the various prophylactic measures, and VTE incidence during the total treatment period for ALL. Secondly, we assessed the clinical relevance of VTE on ALL outcome. Results: 25 of 240 patients (10.4%; 95% CI 6.6–14.3) experienced objectively diagnosed, symptomatic VTE in cycle 1 (10 cerebral thromboses of which 8 in the sagittal sinus, 11 upper limb vein thromboses (10 central venous catheter (CVC)-related), 3 deep vein thromboses of the leg, 1 pulmonary embolism). VTE incidence in patients receiving FFP prophylaxis was reduced by 70% as compared to patients without prophylactic measures (7.2% vs. 23.9%; RR 0.3; 95% CI 0.1–0.6; Table 1). Age, sex, ALL-type and CVC-placement did not differ significantly between patients with and without FFP prophylaxis. The effect of prophylactic AT concentrate could not be properly assessed as it was only rarely given in two centers. Mean AT plasma levels did not differ significantly between VTE patients with or without FFP, neither between patients with VTE and controls without VTE (Figure 1). During the total treatment period, VTE occurred in 36 of 240 patients (15.0%; 95% CI 10.5–19.5). Patients with VTE in cycle 1 were less likely to obtain complete remission after cycle 1 (HR 0.5; 95% CI 0.3–0.9), but did not have a significantly decreased overall survival (HR 1.5; 95% CI 0.9–2.6). Conclusions: FFP significantly reduced VTE incidence by 70% during ALL treatment, without reversing the AT deficiency induced by asparaginase. Our observation is in contrast with two previous studies on the effect of FFP on VTE in ALL. The mechanisms by which FFP accomplishes this antithrombotic effect are not clear yet and require further investigation. Since this was a retrospective, observational study, the effect of prophylactic FFP on VTE risk in adults treated for ALL should be confirmed by a randomized controlled trial. Disclosures: No relevant conflicts of interest to declare.
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Napolitano, Mariasanta, Luca Valore, Giorgia Saccullo, Alessandra Malato, Calogero Vetro, Maria Enza Mitra, Alessandro Lucchesi, et al. "Management of Venous Thromboembolism (VTE) in Patients with Acute Leukemia: Results from a Multicenter Study." Blood 124, no. 21 (December 6, 2014): 3688. http://dx.doi.org/10.1182/blood.v124.21.3688.3688.
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Abstract Background In the last decades, evaluation of thrombotic complications secondary to acute leukemia (AL) has been poorly investigated. Only scant data are available on management and prevention of thrombosis in this setting. We performed a multicenter retrospective study with the aim to evaluate the management of venous thromboembolism (VTE) in patients with AL and to report the most commonly adopted regimens of treatment. Materials and methods Available clinical records of out and in-patients diagnosed with AL from January 2008 to June 2013 in 7 Reference Regional Hospitals were analyzed. Cases of VTE, including thrombosis in atypical sites [Retinal occlusion (RO) and Cerebral Sinus Thrombosis (SCT)], were reported. All data were recorded in a dedicated electronic database. The patient’s basic demographic data (age, gender, race), medical history, disease-related information, and laboratory data were extracted. Instrumental diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE) and RO and SCT was performed according to ACCP guidelines. Data were collected and analysed by the IBM SPSS Software 21.0 version (SPSS, Inc., Chicago, Ill, US) and the Epi Info software, version 3.2.2, (Centers for Disease Control and Prevention). Statistical analysis of quantitative and qualitative data, included descriptive statistics, was performed for all the items. Results Over a population of 1461 patients with AL, 99 (6.8%) cases of VTE were recorded, mainly in hospitalized patients: 72 cases were associated with Acute Myeloid Leukemia (AML) and 27 with Acute Lymphoblastic Leukemia (ALL), with a mean age of 52.2 ± 15.4 years (median age: 53years). In particular the incidence/ratio over the sub-population of AML-patients was 6.0%, that is 72/1191 cases; with a mean age of 54.7 ± 14.3 years (median age: 57 years). VTE occurred during chemotherapy (CHT) in 90/99 (90%) cases, mainly during the induction phase of treatment (in 70% of cases ),the remaining 9 cases were diagnosed in concomitance with acute leukemia. In both subgroups with VT, there was no statistical significant difference between time at diagnosis of VT and time at diagnosis of AL. Treatment of VTE was mainly based on Low Molecular Weight Heparin (LMWH), in accordance with results from previous studies and current guidelines (full dosage for the first month from diagnosis and reduced dosage at 75% for the following months). Thrombocytopenia occurred in 55 patients at diagnosis of AL, in 33 cases platelets were <50x109/L. Most VTE episodes (73/99, 73.7%) were treated with LMWH as above reported . In patients with moderate/severe thrombocytopenia, a dose adjusted to platelet count was adopted; most of the investigators used LMWH at prophylactic dosage. Two cases received fondaparinux, one patient was treated with unfractioned heparin; six cases did not receive any treatment due to severe thrombocytopenia. No cases of VT–related deaths nor fatal complications during treatment for VTE were reported. All treatments with LMWH lasted from 3 to 6 months. All patients clinically recovered from VTE, only 2 late recurrences (PEs) were observed. Conclusion VTE can complicate the clinical course of AL in a not negligible percentage of cases. Anticoagulant treatment schedules and duration in patients with AL are influenced by many factors, mainly related to chemotherapy and severe thrombocytopenia. In the analyzed subset of patients, full dose treatment with LMWH for at least one month followed by a dose reduction for at least three months was appropriate. Disclosures No relevant conflicts of interest to declare.
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Gerotziafas, Grigorios T., Manuella Onambele, L. Benzerara, H. Mokrani, Hela Ketatni, V. Planche, C. Delassasseigne, and Ismail Elalamy. "A Clinic-Genetic Score for Risk Assessment of Recurrent Venous Thrombo Embolism." Blood 128, no. 22 (December 2, 2016): 1428. http://dx.doi.org/10.1182/blood.v128.22.1428.1428.
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Abstract Background Current risk assessment models to predict the risk of recurrent venous thromboembolism (VTE) in an individual patient (i.e Vienna Pedicitive Model, DASH score) include clinical and biochemical parameters and have showed discrimination values ranging from 0.64 to 0.68. Genetic variants associated to thrombophilia have showed to play a relevant role in predicting primary VTE. Combination of those genetic variables together with clinical parameters may improve the predictive capacity of current models for predicting recurrent VTE. Aim To analyze the predictive capacity of a new clinic-genetic score for predicting recurrence of VTE, Thrombo inCode-Recurrent (TiC-Reccurent). Methods A population of 55 patients with a first VTE and none or one or more recurrent VTE (21 males, 34 females; 47.8±14.7 years old) and 39 controls with only the first VTE event (13 males, 26 females; 40.2±13.2 years old) and the same follow-up was used. A regression model was constructed including clinical variants (age, gender, diabetes status, pregnancy status, contraceptive hormonal therapy, smoker status and family history of VTE) and genetic variants (F5 rs6025/rs118203906/rs118203905, F2 rs1799963, F12 rs1801020, F13 rs5985, SERPINC1 rs121909548, and SERPINA10rs2232698 plus the A1 blood group (rs8176719, rs7853989, rs8176743, rs8176750). The predictive capacity was assessed by calculating the c-statistic (AUC-ROC); sensitivity, specificity Positive and Negative Likehoood ratios and odds ratio of a positive test result. Informed consent was obtained and the study was approved by the Institution Ethics Committee. This study complies with the guiding principles for experimental procedures found in the Declaration of Helsinkiof the World Medical Association. Results In an univariate analysis, none of the clinic or genetic variables showed a significant difference between the patient with or without recurrences. TiC-Recurrent score showed a predictive capacity for recurrent VTE measures as AUC-ROC: 0.738, p<0,0001. For TiC-Recurrent the clinical sensitivity was 81.82 and the specificity was 33.33. The predictive capacity measures as LR+, LR- were 1.23 and 0.55, respectively. The odds ratio for TiC-recurrent was 2.7. Conclusions TIC-Recurrent score showed a good predictive capacity to identify subject at high risk of suffering a recurrence of VTE. Although a direct comparison to current scores for predicting the risk for a recurrence of VTE was not possible in the present study if the observed predictive capability for TiC-recurrent is confirmed it will improve the capacity of current scores. Our study suggests that the use of a clinical-genetic algorithm could be an aid in the treatment of patient with a first VTE and contribute to the prevention of VTE recurrences. Disclosures No relevant conflicts of interest to declare.
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Mahan, Charles Edward, Yang Liu, James D. Douketis, Alexander G. G. Turpie, Undaleeb Dairkee, and Alex C. Spyropoulos. "Venous Thromboembolism Validation Study of the IMPROVE Risk Assessment Models in the Medical Patient (VTE-VALOURR),." Blood 118, no. 21 (November 18, 2011): 4218. http://dx.doi.org/10.1182/blood.v118.21.4218.4218.
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Abstract Abstract 4218 Introduction. Venous Thromboembolism (VTE) remains the most common cause of preventable death in hospitalized patients despite more than 25 guidelines and over 5 decades of data on VTE prevention. American College of Chest Physicians (ACCP) and International Union of Angiology (IUA) guideline recommendations are primarily based off of risk factors utilized for entry into randomized controlled trials (RCT) or post-hoc analysis of these RCTs. These guidelines recommend a group-based, as opposed to an individualized risk assessment, approach. It is currently unknown how these risk factors interact in a quantitative manner. There are currently no weighted, validated, VTE risk assessment models (RAM) that are data-derived in medical patients. A retrospective VTE RAM (IMPACT ILL) was recently derived from the multinational IMPROVE registry in hospitalized medical patients. (Table 1) The “VTE-VALOURR ” is a retrospective, multi-center, case control, validation study of this RAM. The VTE-VALOURR is also assessing other VTE and bleeding risk factors. Methods. ICD-10 reports and the McMaster Transfusion Registry for Utilization Surveillance and Tracking (TRUST) database, which contains demographics, transfusion data, and approximately 50 clinical variables including thrombotic outcomes of inpatients, were used as the data source at 3 hospitals. Inclusion criteria were hospitalized medical patients ≥ 18 years with ≥ 3 days length of stay (LOS). Exclusion criteria were patients with pregnancy, mental health disorders, atrial fibrillation/ flutter, trauma, spinal cord injury, surgery within 90 days, VTE within 24 hours of admission, treatment dose anticoagulants (including warfarin) within 48 hours of admission, or transferred from a non-McMaster acute care facility. Lower extremity deep vein thrombosis (DVT) and pulmonary embolism out to 90 days post admission were the thrombotic outcomes of interest and verified by chart review. Upper extremity DVT was excluded. Descriptive statistics (proportions and frequencies) were used to summarize binary variables. Results. From January 1st, 2005 to February 28th, 2011, 247,241 hospitalizations occurred at 3 McMaster hospitals. After exclusionary criteria were applied, 779 VTE events were identified. (Figure 1) Of these, 419 were excluded because they were VTE events not related to a previous hospitalization (i.e. community-acquired). Of the remaining 360 patients, 240 have been reviewed with 93 confirmed, included, VTE events having occurred, 147 events being further excluded, and another 120 patients still requiring review. We present an interim analysis of the 93 currently included patients. Of the included patients, 68 (73%) received some form of prophylaxis during their hospital stay while 35 (38%) received appropriate type, dose and duration of prophylaxis. Fifty-eight (62%) of VTE events were therefore “preventable.” Number of risk factors per patient and risk scores for the 93 patients are listed in tables 2 and 3. Conclusions. Validation of this VTE RAM will identify medical patients at risk of VTE that do not readily fit into group-specific VTE risk categories. Additionally, validation will identify subsets of patients at especially high risk of VTE and focus future randomized controlled trials. Other VTE risk factors may be identified with the study. Review of the 120 VTE cohort patients needs to be completed as well as review of a comparator control cohort. Approximately 80% of the current VTE cohort appears to have a score of 2 or above and be at moderate to high risk of VTE. Final results of approximately 150 VTE patients will be presented along with the control cohort as well as if the model is valid. Disclosures: Turpie: Astellas Pharma Europe: Consultancy; Bayer HealthCare AG: Consultancy; Portola Pharma: Consultancy; sanofi-aventis: Consultancy.
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Wendelboe, Aaron M., Janis Campbell, Micah McCumber, Kai Ding, Dale Bratzler, Michele Beckman, Nimia Reyes, and Gary E. Raskob. "Incidence of Venous Thromboembolism Estimated Using Hospital Discharge Data: Differences Between Event-Based Estimates and Patient-Based Estimates." Blood 124, no. 21 (December 6, 2014): 3508. http://dx.doi.org/10.1182/blood.v124.21.3508.3508.
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Abstract Background Hospital discharge data have been used to estimate the burden of venous thromboembolism (VTE) disease. However, most of these databases are de-identified which limits their utility for estimating VTE incidence due to the inability to identify multiple hospitalizations for the same VTE event, and the inability to differentiate between first-time and recurrent VTE events. Objective We aimed to estimate the magnitude of error in estimates of VTE incidence derived from hospital discharge data by comparing the results obtained when patient identifying information is included, thus enabling us to remove duplicate patient events and stratify by first-time and recurrent VTE events, to the estimates obtained using only de-identified data. Methods In collaboration with the Centers for Disease Control and Prevention (CDC) and the Oklahoma State Department of Health (OSDH), we established a pilot surveillance system for VTE events in Oklahoma County, OK during 2012–2014. The OSHD Commissioner of Health made VTE events reportable conditions from 2010 to 2015 which facilitated our acquisition of hospital discharge data with patient identifiers for years 2010–2012 from the OSDH. The data included the inpatient, outpatient surgical, and ambulatory surgery center discharges. A deep vein thrombosis diagnosis was defined as the presence of any of the ICD-9-CM codes 451.1x, 451.81, 451.83, 453.2, 453.4x, 671.3x, and 671.4x. A pulmonary embolism diagnosis was defined as the presence of either of the ICD-9-CM codes 415.1x and 673.2x. Data were de-duplicated and linked across datasets using Link Plus software incorporating patient identifying variables. Duplicate events for the same person caused by hospital transfers were defined a priori as a second hospital admission with a VTE diagnosis code occurring within 72 hours of the previous discharge date with a VTE present on admission (POA) code for the second admission of “Yes” or “Unknown.” Potentially recurrent events were defined as two hospital admissions of the same patient ≥72 hours apart with a VTE diagnosis. Census Bureau estimates for 2010–2012 were used to define the population at risk in Oklahoma County. Incidence rates (IR) and 95% confidence intervals (CI) were calculated using the Poisson distribution and reported as events per 100,000 population per year. Rate differences and excess fractions were calculated to account for the contribution of recurrent and duplicate events to overall estimates and to differentiate between event-based incidence estimates and patient-based estimates. Results We identified 3,299 unique patients with VTE events. The overall event-based IR for VTE events was 249 (95% CI: 241–257). The IR for potentially recurrent events was 35 (95% CI: 32–38) and for duplicate events caused by patient transfers was 13 (95% CI: 11–14). Thus, the rate difference between event-based estimates and patient-based estimates was 48 (95%CI: 44–51) giving a patient-based IR for first-time events of 201 (95% CI: 194–208). The excess fraction was 19.2% (95% CI: 17.8%-20.5%), of which 14.1% (95% CI: 12.9%–15.2%) is attributed to potential recurrent events and 5.1% (95% CI: 4.4%–5.8%) is attributed to duplicate events caused by patient transfers. Conclusions Using event-based estimates for VTE disease resulted in an over-estimate of the incidence rate of first-time VTE events by up to 20%. Included in this excess estimate is the burden caused by potential recurrent events (14%) and duplicate events caused by patient transfers (5%). We designed our case definitions to accurately measure first-time events, and to capture all duplicate events and potential recurrent events. Assuming these data are representative of national trends, applying these excess fractions to estimates from de-identified data may improve the validity of measuring the incidence of first-time VTE events from de-identified hospital discharge data. Disclosures Bratzler: Centers for Disease Control and Prevention: Consultancy; Sanofi Pasteur: Consultancy. Raskob:Bayer Healthcare: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Janssen Pharmaceuticals: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; ISIS Pharmaceuticals: Consultancy, Honoraria.
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Juthani, Prerak V., Danya Muneer Ahmed, Osama Muneer Ahmed, Robert D. Bona, Natalia Neparidze, and Alfred Ian Lee. "Venous Thromboembolism (VTE) Education Preferences Amongst Physicians and Patients: A Qualitative Needs Assessment." Blood 132, Supplement 1 (November 29, 2018): 5810. http://dx.doi.org/10.1182/blood-2018-99-119418.
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Abstract Introduction: Venous thromboembolism (VTE) is the leading cause of preventable deaths in hospitalized patients. Prior studies have demonstrated that increasing patient education about VTE increases medication adherence. Thus, standardizing VTE education is an important priority in optimizing patient care. In this regard, online education offers unique advantages as it can be accessed by patients anywhere and anytime. However, an effective VTE educational tool remains elusive as little research has been done to determine what information patients should know or how such information can be delivered most effectively. We performed a qualitative study of hematologists and VTE patients to understand these issues, with the goal of utilizing this information to create an online educational tool for VTE that addresses the needs of both clinicians and patients. Methods: We conducted semi-structured interviews with physicians in the Section of Hematology at Yale School of Medicine (YSM) and VTE patients in the outpatient Benign Hematology Clinic at Yale Cancer Hospital. Adult patients with a pulmonary embolism or deep venous thrombosis, who were on or off anticoagulation, and who were seen in the outpatient clinic either as new patients or for follow-up visits were all included. Providers were asked about what strategies work best when communicating to patients and important aspects of VTE they felt patients should know. Patients were asked about their understanding of VTE and how an educational tool would best address their concerns. All interviews were audio recorded and transcribed. Data were analyzed with grounded theory, and each transcript was double-coded until thematic saturation was achieved. Results: Five physicians participated in the study: one with a focus in benign hematology, three with a focus in benign and malignant hematology, and one who had been a private practice hematology/oncology provider and then transitioned into a clinical appointment on the YSM Hematology faculty. Qualitative analysis from the physician interviews revealed important themes. In particular, physicians believed that an online resource for VTE should: 1) provide visual animation to facilitate conceptual understanding; 2) be readily accessible and as concise as possible; and 3) follow a standardized format that addresses classification of VTE (provoked vs. unprovoked), signs and symptoms of VTE, treatment options, and long-term management. Eight patients were interviewed for the study, 4 with a first episode of VTE and 4 with recurrent VTE. Of these, 7 were on anticoagulation and 1 was not. Most patients indicated that their major source of online health education was through websites - most notably "WebMD." Patients identified websites as helpful in providing background information, but felt that websites were limited in their ability to provide personalized patient-based recommendations. Many also found website text lengthy and felt that concepts could be better conveyed if explained visually in a concise manner. Conclusion: Based on the physician and patient interviews, an optimal online educational tool about VTE should address the pathophysiology, natural history, management, recurrence risk, and prevention of VTE, in a concise and personalized manner, utilizing visual stimuli. We plan on synthesizing this information to create a 5-10 minute animated video about VTE that addresses all of these issues; we then hope to study the efficacy of the video through a randomized control trial. Disclosures No relevant conflicts of interest to declare.
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Dubey, Apurva, Sourya Acharya, Samarth Shukla, and Sunil Kumar. "Cerebral Venous Sinus Thrombosis (CVST) in a Young Female with COVID-19 Infection and Oral Contraceptive Pill Ingestion Double Hit? – A Case Report." Journal of Evolution of Medical and Dental Sciences, no. 35 (August 30, 2021): 3060–62. http://dx.doi.org/10.14260/jemds/2021/623.
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The Chinese centre for disease control and prevention detected a novel severe acute respiratory syndrome - coronavirus 2 (SARS - CoV2) from a nasopharyngeal swab in a patient with atypical pneumonia in Wuhan, Hubei province, China on January, 2020.1 Corona virus disease-19 (COVID-19) has a high mortality rate in critically ill patients. Acute heart injury, acute kidney injury and sudden thromboembolic events are becoming more common and they can occur regardless of pulmonary or respiratory symptoms.1-5 COVID-19 has been shown to have the ability to create a hypercoagulable state in recent studies.2,3,6,7 Viral infections can cause endothelial cell dysfunction, resulting in excessive throbbing production and fibrinolysis inhibition.8- 10 Hypoxia is also linked to an increase in blood viscosity and the activation of hypoxia-related genes that regulate coagulation and fibrinolysis making thrombotic events more likely.11,12 This septic-like coagulopathy can also lead to venous thrombosis, pulmonary embolism, and, in the worst-case scenario, disseminated intravascular coagulation.3,4 Cerebral venous thrombosis, in particular, can manifest itself in a wide range of neurologic signs and symptoms.13,14 and had consistently fatal results.
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Ansell, Jack E., Gregory A. Maynard, Richard J. Friedman, Elizabeth A. Varga, Lisa L. Fullam, and Alan P. Brownstein. "Deep Vein Thrombosis and Pulmonary Embolism: Awareness and Knowledge Gaps In the General Public." Blood 116, no. 21 (November 19, 2010): 4731. http://dx.doi.org/10.1182/blood.v116.21.4731.4731.
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Abstract Abstract 4731 Deep vein thrombosis (DVT) and pulmonary embolism (PE) impose a major public health burden in the United States, affecting an estimated 350,000 to 600,000 individuals and accounting for ~100,000 deaths in the United States each year, according to The Surgeon General's Call to Action (CTA) To Prevent Deep Vein Thrombosis and Pulmonary Embolism (2008). In response to this CTA, the National Blood Clot Alliance (NBCA), a national, community-based, non-profit organization dedicated to the prevention, diagnosis, and treatment of thrombosis and thrombophilia, conducted a survey to benchmark DVT/PE awareness among the general public. Little information about the public's knowledge of venous thromboembolism (VTE) is found in the literature, making this one of the most comprehensive, relatively large surveys of its kind. This DVT/PE awareness survey was conducted in November 2009, among a representative cross-section of 500 adults, >20 years, participating in online research panels. Among all respondents surveyed, just 21% said that they had heard of a medical condition called DVT (unaided), and, among this group (n=104), 86% correctly identified it as “deep vein thrombosis” on an aided checklist. Among those respondents who had not heard of a DVT or who had made an incorrect checklist selection (n=411), when DVT was identified for them as “deep vein thrombosis,” 29% then said they knew what it was. Among all respondents, just 16% said that they had heard of a medical condition called PE, and, among this group (n=80), 83% identified it correctly as “pulmonary embolism” on an aided checklist. Awareness of specific DVT risk factors and DVT/PE signs/symptoms was low. Results of this survey show that the medical lexicon poses substantial barriers: only 23% of all respondents reported to know what thrombophilia means and just 9% had heard of VTE. Conversely, 8 in 10 of all respondents said that they do know what a blood clot is, and virtually all respondents (98%) said that they believe blood clots can be life-threatening. The leading factors respondents said they believe are risks for causing blood clots included: family history of blood clots (73%), major trauma (71%), major surgery (69%), and being bedridden (68%), while <60% of respondents mentioned other risk factors, such as cancer, chemotherapy, pregnancy, hormone therapy and birth control pills, or age. The public health impact of DVT/PE is significant, while DVT/PE public awareness, including awareness of important DVT/PE risk factors and signs/symptoms, is disproportionately low. These survey data support recommendations in the Surgeon General's CTA, underscoring the urgent need for education, especially the use of simplified terms, to close gaps in DVT/PE public awareness/knowledge, and can help guide educational initiatives relative to DVT/PE that may contribute to decreased morbidity and mortality. Disclosures: Ansell: Bayer, Inc: Consultancy; Bristol Myers Squibb: Consultancy, Data Safety Monitoring Boards; Daiichi Sankyo: Consultancy; Boehringer Ingleheim: Consultancy; Ortho McNeil: Consultancy; Sanofi Aventis: Speakers Bureau. Brownstein:Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.: Data reported from project supported by Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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Bosson, Jean Luc, Marie Antoinete Sevestre, Jose Labarere, Joel Constans, Isabelle Quere, and Gilles Pernod. "Recurrence and Mortality of DVT-Associated PE Is Greater Than Isolated PE Alone: Results of the 7532-Patients Prospective OPTIMEV Cohort Study." Blood 110, no. 11 (November 16, 2007): 700. http://dx.doi.org/10.1182/blood.v110.11.700.700.
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Abstract Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with a significant mortality and life-long morbidity. A large number of studies have focused on VTE, contributing to better improving its management. Especially studies have provided accurate estimates of 3-month mortality rates for PE and have identified prognostic factors that may guide the physician’s initial treatment decision for these patients. However, improvements in the prevention of venous thromboembolism (VTE) and diagnosis have changed the epidemiology of VTE over the last twenty years. Advances in imaging technology have resulted in more frequent diagnosis and treatment of early presentation of VTE, including isolated distal DVT or isolated PE. However, the clinical signification and the prognosis of these forms of VTE are unknown. Therefore we prospectively investigated the 3-month overall for isolated distal DVT, proximal DVT, PE with DVT and PE without DVT, among a large in and out population study. Between November 2004 and January 2006, all patients over 18 years old who were referred to 359 french board-certified vascular physicians for a clinical suspicion of VTE were included. VTE presentations were categorized using validated clinical decision rules and objective tests including ultrasonography, lung scan and helical CT scan. Subjects without an objectively confirmed diagnosis of VTE were used as controls. All patients with confirmed VTE and a random sample of controls were followed-up at 3 months. We estimated 3 months survival for each type of VTE 8256 patients entered the study, among which 7532 were analysed. The median age for all patients was 65 years (49–77 years), 2923 (39%) were men, 2925 were inpatients (39%), and 1884 (25%) had a previous history of VTE. 933 had isolated distal DVT (12%), 710 proximal DVT (9.4%), 426 PE with DVT (5.7%), 148 PE without DVT (2.0%) and 5315 had no VTE (70.6%). Overall, 4290 patients were followed up at 3 months. At 3 months, VTE recurrence was not significantly different between the 5 groups of patients. By contrast, 95/2407 control patients (4%), 35/787 (4.4%) distal DVT, 48/598 (8%) proximal DVT, 48/371 (12.9%) PE with DVT, and 6/130 (4.6%) died. In multivariate analysis, the 3-months mortality adjusted hazard ratio [95% CI] was 1.1 [0.7–1.7] for distal DVT (P 0.59), 1.6 [1.1–2.3] for proximal DVT (P 0.013), 2.1 [1.4–3.0] for DVT-associated PE (p<0.01), and 0.5 [0.2–1.1] for isolated PE (P 0.084). Kaplan-Meier survival estimates were 96% [95% CI 95–97] for controls as compared with 95% [94–97], 92% [90–94], 87% [83–90] and 95% [90–98] for isolated distal DVT, proximal DVT, PE with DVT, and PE without DVT cases, respectively (Figure 1). Therefore, compared to controls, only patients with proximal DVT or PE with DVT were at increased risk of death, while patients with isolated PE without DVT were not. Figure Figure
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Allaert, François-André, Eric Benzenine, and Catherine Quantin. "Hospital incidence and annual rates of hospitalization for venous thromboembolic disease in France and the USA." Phlebology: The Journal of Venous Disease 32, no. 7 (October 4, 2016): 443–47. http://dx.doi.org/10.1177/0268355516653005.
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Objective The study was designed to describe the hospital incidences and annual hospitalization rates for venous thromboembolic disease by age and sex in France and the United States on the closest possible methodological bases. Methods French statistics are from the PMSI MCO (Programme de médicalisation des système d'information de médecine, chirurgie et obstétrique (French national hospital discharge register)) national database. These are compiled for each calendar year by collating résumé de sortie anonymisé (RSA, anonymous discharge summary) files forwarded and validated by health establishments with admissions in medicine, surgery, obstetrics, and odontology. They are compared to the data issued from the US National Hospital Discharge Survey which is equivalent to the PMSI in France and uses the International Classification of Diseases-9 for encoding the data. These data were published in the Morbidity, Mortality Weekly Report of the Centre for Disease Control. Results In the US, 547,996 hospital stays involve venous thromboembolic diseases, 348,558 deep venous thrombosis (DVT), and 277,549 pulmonary embolism (PE). Of these 78,511, or 14%, include a diagnosis of both DVT and PE. The hospital incidence of venous thromboembolic disease is 1.4%, DVT 0.9%, and PE 0.7%. In France, of the 26,658,228 annual hospital stays, 273,931 include venous thromboembolic disease, 179,286 DVT, and 139,345 PE while 44,700, i.e. 16.3%, include both DVT and PE. The hospital incidence of venous thromboembolic disease is thus 1.0%, DVT 0.6%, and PE 0.5%. The overall annual hospitalization rates for venous thromboembolic disease, DVT, and PE are respectively 274, 179, and 139 per 100,000 inhabitants in France and 239, 146, and 121 per 100,000 inhabitants in the US. Conclusion Venous thromboembolic diseases occur in France and the US in 1% of all hospital stays and are responsible for an annual hospitalization rate that exceeds 200 per 100,000. The scale of these annual incidences should prompt us to question the quality of prevention put in place and/or its efficacy.
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Philippe, Debourdeau, Farge Dominique, Beckers Marielle, Caroline Baglin, Rupert Bauersachs, Benjamin Brenner, Dialina Brilhante, et al. "International Clinical Practice Guidelines for the Treatment and Prophylaxis of Thrombosis Associated with Central Venous Catheters in Patients with Cancer." Blood 120, no. 21 (November 16, 2012): 4357. http://dx.doi.org/10.1182/blood.v120.21.4357.4357.
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Abstract Abstract 4357 Background Use of long term indwelling central venous catheter (CVC) is associated with symptomatic (Σ) events in up to 30% of cancer patients (pts), which may lead to pulmonary embolism (PE) and loss of the CVC. Lack of consensus on management of CVC related thrombosis (CVCT) and heterogeneity in clinical practices worldwide led us to establish international Good Clinical Practices Guidelines (GCPG) for the management of CRT in cancer pts. Methods The international working group (WG) met 4 times and worked 2 years with the methodological support and quality control of the French institute of Cancer (INCa). All studies on cancer, venous thromboembolism (VTE, including pulmonary embolism PE), and anticoagulant drugs (AC) published from 1996 to 2011 weree searched using MEDLINE®database. Meta-analyses, systematic reviews, randomized or non-randomized prospective or retrospective studies in the absence of randomized clinical trials, and abstracts only if a full paper had been accepted in a peer-reviewed medical journal were included in the analysis. The included studies concerned the prophylaxis and treatment of CVC in cancer pts. Studies in non-cancer pts, pts with a peripheral or dialysis catheter, or with a history of cancer in remission for more than 5 years were not considered. The main study outcomes were rates of proven catheter related thrombosis (CRT), extension of CRT, PE associated with CRT, major and minor bleeding, thrombocytopenia, and death. Quality of the studies was evaluated in a double-blind manner by the methodologists using the GRADE appraisal grids. Extracted data were entered in evidence tables, subsequently validated by all the WG. The level of evidence (High A, Moderate B, Low C, Very low D) depended on study design, limitations, inconsistency, indirectness, imprecision and publication bias. For each question, results analysis were summarized and discussed by the WG. Overall conclusions and recommendations were classified as Strong (Grade 1 Guideline) or Weak (Grade 2 Guideline) based on evidence levels, the balance between desirable/undesirable effects, values and preferencesand costs. In the absence of scientific evidence, judgment based on consensus within the WG was defined as Best Clinical Practice (BCP). The GCP were reviewed and evaluated using a specific grid in February 2012 by 45 independent experts in managing cancer pts worldwide and 3 pt representatives. Results Conclusion Dissemination and implementation of these international GCPG on the prevention and treatment of CRT in cancer ptsat each national level is a major public health priority, necssitating world wide collaboration. Disclosures: No relevant conflicts of interest to declare.
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Meier, Bernhard. "Closing the Patent Foramen Ovale with Amplatzer Devices." European Cardiology Review 5, no. 1 (2009): 71. http://dx.doi.org/10.15420/ecr.2009.5.1.71.
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The relative risk of a thromboembolic event is four-fold higher in the 25–35% of adults with a patent foramen ovale (PFO) and 33-fold higher in patients who also have an atrial septal aneurysm. The American PICSS trial showed a yearly incidence of stroke or death after an initial event of 5% with warfarin and 9% with acetylsalicylic acid. The presence of a PFO more than doubles the mortality rate in patients with clinically relevant pulmonary embolism. The risk of a PFO increases with age. Proof of effectiveness in migraine alleviation is likely to be achievable in a couple of years – much quicker than in prevention of paradoxical embolism. Percutaneous closure of PFO has been performed with various devices at the University Hospital Bern in Switzerland since April 1994, with over 1,000 patients treated. At the last available transoesophageal echocardiogram, a significant residual shunt persisted in 4% with Amplatzer devices and 17% with other devices. During follow-up, a recurrent embolic event was observed in 1.6% of patients per year – less than would be expected under medical treatment. Several randomised multicentre trials comparing catheter closure with medical treatment have been started. The PC and CLOSURE trials are in the follow-up phase; results cannot be expected before 2010, and they may well be ‘falsely’ neutral because the follow-up is rather short for the low-risk patients randomised. In a matched control study on patients with cryptogenic stroke and a PFO, 158 patients were treated medically and 150 concomitant patients underwent percutaneous PFO closure. At four years, PFO closure resulted in a trend towards risk reduction of death, stroke or transient ischaemic attack (TIA) (9 versus 24%; p=0.08) compared with medical treatment. The calculated occurrence of patients with cryptogenic strokes associated with a PFO amounts to somewhere between 100 and 300 per year and per million population, corresponding to more than 10% of yearly coronary angioplasty cases. Coronary and peripheral paradoxical emboli without prior exclusion of competing causes plus the presumed associations between PFO and migraine or decompression illness in divers open additional vast fields of potential indications for catheter closure. Finally, the linearly decreasing prevalence of a PFO with age suggests a weeding out of PFO carriers (unless spontaneous closure is assumed). A PFO represents a lethal threat that increases with age. It can be closed percutaneously in 15 minutes virtually free of complications. The patient can resume unrestricted physical activities a few hours after the intervention.
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Sibai, Hassan, Ruiqi Chen, Xing Liu, Aaron D. Schimmer, Andre Schuh, Arjun Law, Caroline J. McNamara, et al. "Anticoagulation Prophylaxis with Weight-Adjusted Enoxaparin Reduces Rates of Venous Thromboembolism in Patients with Acute Lymphoblastic Leukemia Receiving Asparaginase-Based Intensification Therapy." Blood 132, Supplement 1 (November 29, 2018): 3974. http://dx.doi.org/10.1182/blood-2018-99-119984.
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Abstract Background Venous thromboembolism (VTE) is a well-known complication in adults receiving asparaginase (ASNase)-based intensification chemotherapy for acute lymphoblastic leukemia (ALL). The optimal preventative strategy is unclear. We previously reported high thrombosis rates during intensification without VTE prophylaxis. Our objective is to determine the effects of weight-adjusted enoxaparin as primary VTE prophylaxis in ambulatory adults receiving ASNase-based intensification chemotherapy for ALL. Methods Patients who achieved complete remission following induction from 2011-2017 went on to receive ASNase-based intensification on the Dana Farber Cancer Institute (DFCI) 91-01 protocol. Patients already on therapeutic anticoagulation for prior VTE were excluded. VTE prophylaxis commenced on day 1, cycle 1 of intensification until the completion of the entire 21-30 week. From 2011 to 2014 patients received enoxaparin subcutaneously once daily, at a dose of 40 mg for patients weighing less than 80 kg, and 60 mg for those 80 kg and over for the first 3 years. Due to continuing occurrence of VTE from 2014-2017 patients received an escalated dose aiming at 1mg/kg daily (rounded to the nearest 20 mg). Results were compared to an historical patient cohort that received the same regimen without VTE prophylaxis prior to 2011. Result: In our historical cohort of adult ALL that did not receive prophylactic anticoagulation (n=99), the rate of VTE was 27%. 124 patients received one of the above prophylactic anticoagulation schedules. The treated and control groups did not differ with respect to median age, gender, weight and number of ASNase treatment cycles per patient. 16 of 124 patients (12.9 %) in the prophylaxis groups developed symptomatic VTE. Sites of VTE in the prophylaxis group included lower extremity (10), sagittal sinus (2), subclavian line related (3), and pulmonary embolism (4). There were no major bleeding complications observed in the prophylaxis group. In the first patient cohort (n=42), receiving fixed enoxaparin doses of 40 or 60 mg, dosing ranged from 0.39-0.69 mg/kg. The mean enoxaparin dose administered was 0.57 mg/kg. Seven (16.6 %) developed a symptomatic VTE, which was not significantly different from the historical non-prophylaxis cohort. In the second patient cohort (n=82), all patients received weight-adjusted enoxaparin > 0.7 mg/kg of enoxaparin. The mean enoxaparin dose administered was 0.88 mg/kg. Nine of 82 patients (10.9 %)) in this cohort had a symptomatic VTE, which was lower than the historical cohort (OR = 0.33 {95% CI, 0.15-0.77} and P< 0.01). Conclusions: Weight-adjusted enoxaparin prophylaxis targeting 1 mg/kg/day reduced the incidence of symptomatic VTE in adult ALL patients receiving intensification chemotherapy with ASNase. This treatment is a viable VTE prevention option with no documented major bleeding. Disclosures Schimmer: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Otsuka Pharmaceuticals: Consultancy; Medivir AB: Research Funding; Jazz Pharmaceuticals: Consultancy. Schuh:Teva: Consultancy; Jazz: Consultancy; Pfizer: Consultancy; Amgen Inc.: Consultancy; Celgene: Consultancy; Novartis: Consultancy; Shire: Consultancy; Otsuka: Consultancy. Maze:Novartis: Consultancy, Honoraria. Yee:Celgene, Novartis, Otsuka: Membership on an entity's Board of Directors or advisory committees; Agensys, Astex, GSK, Onconova, Genentech/Roche: Research Funding. Gupta:Incyte: Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Brandwein:Pfizer: Consultancy; Celgene: Consultancy; Lundbeck: Consultancy; Novartis: Consultancy; Boehringer Ingelheim: Consultancy, Research Funding.
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Savic, Dejan, and Ljiljana Savic. "Vein thromboembolism prevention in stroke patients." Medical review 63, no. 3-4 (2010): 220–26. http://dx.doi.org/10.2298/mpns1004220s.
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Introduction Having in mind the rate of occurrence and clinical importance, venous thromboembolism implies venous thrombosis and pulmonary embolism as a result of embolisation of the thrombotic particles from deep veins or pelvic veins. Venous thrombosis of the deep veins may result in chronic vein insufficiency, but the primary medical problem is the possibility of development of pulmonary embolism which may cause permanent respiratory function damage or even fatal outcome. Venous thromboembolism prevention in stroke The high incidence of deep vein thrombosis (30% clinically and up to 50% subclinically) in acute stroke hemiparetic and bed ridden patients within two weeks from the onset and 1-2% pulmonary embolism with the fatal outcome in the first month clinically and 17% of all fatal outcomes in postmortem investigations present a necessity for the early venous thromboembolism prevention. On the other hand, the most powerful prevention strategy - anticoagulation has important limitations in acute stroke patients: almost impossible to be used in cerebral haemorrhage and a great risk for the development of hemorrhagic transformation in cerebral infarction. The fact that other prevention strategies have limited value requires an estimation of efectivity-risk ratio in venous thromboembolism prevention in stroke. Conclusion Venous thromboembolism prevention in stroke patients is necessary because of a greater risk for venous thromboembolism in these patients according to the nature of illness and functional disability, but also a problem because of limited possibility to recommend the proper medicament according to the risk of serious complications. The necessity of preventing venous thromboembolism and estimation of efficiency-risk ratio in stroke patients, beside plenty of studies and consensus conferences, remain individual and often very difficult.
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Diamantopoulos, Alexander, Corrine LeReun, Farhat Rasul, Michael Lees, Maria Kubin, and Philip Wells. "Indirect Comparisons of Rivaroxaban Versus Alternative Prophylaxes for the Prevention of VTE in Patients Undergoing Total Knee Replacement." Blood 112, no. 11 (November 16, 2008): 1292. http://dx.doi.org/10.1182/blood.v112.11.1292.1292.
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Abstract Introduction: Rivaroxaban is a novel, oral, direct Factor Xa inhibitor under regulatory review for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery. Two large, randomized controlled trials compared 10 mg rivaroxaban once daily (od) with subcutaneous (sc) enoxaparin 40 mg od (RECORD3) and enoxaparin 30 mg twice daily (bid)(RECORD4) in patients undergoing total knee replacement (TKR). Rivaroxaban and enoxaparin were administered for 12 ± 2 days in both trials. In RECORD3, rivaroxaban was associated with a relative risk reduction (RRR) of 49% in total VTE (composite of any deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality) and 66% in symptomatic VTE versus enoxaparin (p=0.005). In RECORD4, rivaroxaban reduced total VTE versus enoxaparin (RRR 32%, p=0.012). There was no statistical difference in major bleeding between rivaroxaban and enoxaparin in either study. Although the comparison between rivaroxaban and enoxaparin is important, there are alternative VTE prophylaxes such as warfarin, fondaparinux and dabigatran (which received EU marketing approval in March 2008) for which there are no direct comparisons with rivaroxaban. This analysis was designed to assess the relative efficacy and safety of rivaroxaban versus warfarin, fondaparinux and dabigatran. This is important for clinical decision makers, but also provides important inputs for cost-effectiveness analyses of rivaroxaban versus these comparators. Methods: The efficacy of rivaroxaban relative to warfarin, fondaparinux and dabigatran was assessed by comparing the occurrence of total VTE, total DVT (proximal and distal) and symptomatic DVT. Relative safety was assessed using rates of major bleeding. A systematic literature review identified randomised control trials (RCTs) comparing enoxaparin to warfarin, fondaparinux or dabigatran in TKR. Each of these publications was reviewed by independent analysts. Data for relevant efficacy and safety outcomes were taken from these studies, and from RECORD3 and 4 for rivaroxaban versus enoxaparin. If more than one set of RCTs were available for each comparator, a meta-analysis was undertaken to obtain the pooled results for efficacy and safety (Bucher et al., 1997). Indirect comparisons were conducted based on the summary statistics obtained in each meta-analysis. Results are presented for the indirect comparisons through enoxaparin 30 mg bid and enoxaparin 40 mg od separately. The results from such an analysis do not represent the same level of evidence as a comparative trial, but they provide a guide to potential relative efficacy and safety in the absence of a comparative trial and could be used by authorities to aid decision making (NICE, 2007). Results: Rivaroxaban significantly reduced the incidence of key outcomes. When enoxaparin 30 mg bid was used as the common comparator, rivaroxaban was associated with reductions in total VTE of 56% versus warfarin (p<0.001) and 29% versus dabigatran (p<0.05). When enoxaparin 40 mg od was used as the common comparator, rivaroxaban was associated with reductions in total VTE of 67% versus warfarin (p<0.001) and 47% versus dabigatran (p<0.001). Similar reductions were shown in total DVT. No other statistically significant differences, including for the comparison with fondaparinux, were found. Importantly for a new anticoagulant, there were no increases in major bleeding with rivaroxaban, safety outcomes are therefore unlikely to influence cost-effectiveness. Conclusions: An indirect statistical comparison showed that rivaroxaban reduced the incidence of overall or symptomatic VTE events relative to alternative prophylaxes without increasing major bleeding following TKR. In the absence of direct comparisons, this is the best evidence regarding the relative efficacy and safety of these options.
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Shaw, Joseph, Gregoire Le Gal, Melanie Tokessy, Nancy Cober, Elianna Saidenberg, Marc Carrier, and Lana Castellucci. "FEIBA™ for Reversal of Direct Oral Anticoagulant Associated Major Bleeding." Blood 124, no. 21 (December 6, 2014): 1540. http://dx.doi.org/10.1182/blood.v124.21.1540.1540.
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Abstract Introduction: Direct oral anticoagulants (DOACs) are indicated for the prevention of systemic embolism in patients with atrial fibrillation and for the prevention and treatment of venous thrombosis. Although DOACs offer advantages over the vitamin K antagonists, some hesitancy remains over their use given the lack of specific antidotes for management of life threatening bleeding events. In vivo studies, case reports and case series have shown that prothrombin complex concentrate (PCC) and activated PCC might potentially be used to control life threatening bleeding in patients with DOAC-associated bleeding episodes. Herein we describe management and outcomes of DOAC-associated life threatening bleeding events using an activated PCC (FEIBA™). Methods: A retrospective review of patients presenting with DOAC-associated (dabigatran, rivaroxaban or apixaban) life threatening bleeding to The Ottawa Hospital between January 2013 and June 2014 are included. Patients received 25 – 50 units/kg of FEIBA™. The primary outcome was adverse thrombotic and embolic events during follow-up. Secondary outcome was symptomatic control of bleeding. Results: Nine patients presented to hospital with life threatening bleeding episodes (post trauma: n=3; spontaneous bleeding: n=6). Spontaneous episodes included epistaxis or gastro-intestinal bleeding. Baseline characteristics are depicted in Table 1. A majority of patients had atrial fibrillation (n=8) and received rivaroxaban (n=5). The last dose of DOAC was taken within 24 hours of bleeding events for all patients. All patients received supportive management, interventions/procedures aimed at attaining source control of bleeding when possible, and transfusion of FEIBA™ for reversal of anticoagulant effect. Adverse events after receiving FEIBA™ were uncommon with one patient experiencing a TIA with expressive aphasia and visual field deficit on the evening of FEIBA™ transfusion; deficits resolved by the time of hospital discharge. Two patients with GI bleeding continued to have ongoing bleeding despite FEIBA™ administration and two patients died as a result of major bleeding. Conclusions: In this cohort of patients with major bleeding associated with DOACs, FEIBA™ administration, in addition to supportive care, was helpful in minimizing further complications of most bleeding events and associated with a low rate of adverse events. Prospective studies are needed to evaluate benefits and harms of FEIBA™ for management of DOAC associated major bleeding. Abstract 1540. Table 1: Patients with Life-threatening Bleeding Patient (Age and Gender) Indication for DOAC [AF(CHADS2); VTE] DOAC and Dosage Site of Bleeding Intervention/ Procedure Units of PRBCs Transfused Additional Treatment FEIBA™ Dose (IU)(1st/2nd) Adverse Events post-FEIBA™ Administration Survived Hospitalization 85 Male AF (2) Rivaroxaban 20 mg daily Epistaxis Nasal Packing 0 -- 3275 -- Yes 86 Male AF (2) Rivaroxaban 20 mg daily LGIB Angiogram, no embolization performed 10 Vitamin K 3159/ 2952 -- Yes 84 Male AF (2) Dabigatran 110 mg BID Orbital vitreous hemorrhage Surgical repair of ruptured globe 0 -- 1812 -- Yes 92 Male AF (6) Apixaban 5 mg BID Left hand Conservative management 1 Tranexamic acid 2718 TIA Yes 85 Male VTE Rivaroxaban 20 mg daily LGIB Conservative management 2 Vitamin K 1740 -- Yes 90 Female AF (5) Rivaroxaban 20 mg daily SDH Conservative management 0 -- 3275 -- No; died of major bleed 93 Female AF (6) Apixaban 2.5 mg BID LGIB Conservative management 4 -- 2241 -- No 93 Male AF (3) Rivaroxaban 15 mg daily UGIB Upper endoscopy, no intervention 4 Vitamin K 3000 -- No; died of major bleed and septic shock 81 Male AF (4) Dabigatran 110 mg BID LGIB Upper endoscopy and colonoscopy, no interventions 4 -- 3362 -- No AF = atrial fibrillation; BID = twice daily; CHADS = congestive heart failure, hypertension, age, diabetes, stroke; DOAC = direct oral anticoagulant; IU = international units; LGIB = lower gastrointestinal bleeding; PRBC = packed red blood cells; SDH = subdural hematoma; TIA = transient ischemic attack; UGIB = upper gastrointestinal bleeding; VTE = venous thromboembolism Disclosures Off Label Use: FEIBA is an activated prothrombin complex concentrate that was used during management of life threatening bleeding in patients with direct oral anticoagulant-associated bleeding episodes..