Journal of thrombosis and thrombolysis
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J. Thromb. Thrombolysis · Oct 2011
Randomized Controlled Trial Clinical TrialLocal and systemic application of tranexamic acid in heart valve surgery: a prospective, randomized, double blind LOST study.
The study was performed to examine a possible augmentation of systemic administration of tranexamic acid by the additional topical application during heart valve surgery in the post-aprotinin era. One-hundred patients were enrolled in the study and all the patients were given tranexamic acid intravenously. The participants were randomized into two groups (A, n = 49; B, n = 51), and before commencing the sternal suturing, the study solution (group A: 250 ml of normal saline + tranexamic acid 2.5 g, placebo group B: 250 ml of normal saline) was poured into the pericardial cavity. ⋯ Twenty-four hours postoperatively the blood loss was 504.2 [436.0, 583.0] ml in group A, 569.7 [476.0, 681.7] ml in group B, P = 0.293 and P = 0.014, respectively. The proportion of patients transfused postoperatively by fresh frozen plasma differed significantly between the two study groups (group A: n = 21, group B: n = 36, P = 0.008). Our hypothesis is supported by a significant difference in the inter-group variance of blood loss and the proportion of patients requiring fresh frozen plasma; however evident differences in mean postoperative blood loss were not statistically significant.
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J. Thromb. Thrombolysis · Aug 2011
Randomized Controlled Trial Multicenter StudyChromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban--an oral, direct and selective factor Xa inhibitor.
An ability to readily determine an anticoagulant effect with an emerging class of direct, active site, oral factor Xa inhibitors is viewed by the medical community as attractive and by some as an absolute requirement for their use in clinical practice. We performed a pharmacokinetic and pharmacodynamic substudy in APPRAISE-1-a study of apixaban in patients with acute coronary syndrome(ACS). A total of 1691 patients had blood sampled for apixaban plasma concentrations using mass spectrometry/high performance liquid chromatography and anti-Xa activity using a chromogenic assay employing either low molecular weight heparin or apixaban as reference standards. ⋯ The correlations for each method were equally strong at low (<100 ng/ml) (r = 0.86, P < 0.0001; r = 0.85, P < 0.0001), intermediate(100-200 ng/ml) (r = 0.73, P < 0.0001; r = 0.69, P < 0.0001) and high (>200 ng/ml) (r = 0.91, P < 0.0001; r = 0.91, P < 0.0001) plasma concentrations of apixaban, respectively. Our pharmacokinetic and pharmacodynamic substudy suggests that an apixaban-mediated anticoagulant effect can be detected even at very low plasma concentrations using a standard laboratory chromogenic anti-Xa assay with either LMWH or apixaban calibrators. While establishing parameters for safety and efficacy will require further investigation, an ability to discern the presence of a drug effect may provide clinically useful information.
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J. Thromb. Thrombolysis · May 2011
Randomized Controlled Trial Multicenter StudyExtended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol.
Patients with acute medical illnesses are at increased risk of venous thromboembolism (VTE), a significant cause of morbidity and mortality. Thromboprophylaxis is recommended in these patients but questions remain regarding the optimal duration of therapy. The aim of this study is to determine whether oral rivaroxaban is non-inferior to standard-duration (approximately 10 days) subcutaneous (s.c.) enoxaparin for the prevention of VTE in acutely ill medical patients, and whether extended-duration (approximately 5 weeks) rivaroxaban is superior to standard-duration enoxaparin. ⋯ As of July 2010, 8,101 patients from 52 countries have been randomized. These patients have a broad range of medical conditions: approximately one-third were diagnosed with acute heart failure, just under one-third were diagnosed with acute infectious disease, and just under one-quarter were diagnosed with acute respiratory insufficiency. MAGELLAN will determine the efficacy, safety, and pharmacological profile of oral rivaroxaban for the prevention of VTE in a diverse population of medically ill patients and the potential of extended-duration therapy to reduce incidence of VTE.
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J. Thromb. Thrombolysis · Jan 2009
Randomized Controlled Trial Multicenter Study Comparative StudyPlatelet and endothelial activity in comorbid major depression and coronary artery disease patients treated with citalopram: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy Trial (CREATE) biomarker sub-study.
Major depression is an independent risk factor for increased morbidity and mortality in patients with coronary artery disease (CAD). Increased platelet activity and vascular endothelial dysfunction are possible pathways through which depression may increase cardiovascular risk. Citalopram exhibits strong selective inhibition of human platelet activation, but little is known about its effects on vascular endothelium. We assessed whether treatment of depressed CAD patients with citalopram alters platelet/endothelial biomarkers. The study was performed within the framework of the CREATE trial. ⋯ Treatment with citalopram for 12 weeks in depressed CAD patients is associated with enhanced production of nitric oxide despite the co-administration of commonly prescribed anti-platelet regimens including aspirin and clopidogrel. Clinical implications of these findings are unclear, but improved endothelial function is implied by the increased NO production, suggesting that citalopram may be of particular benefit for patients with comorbid depression and vascular disease including CAD, stroke, peripheral artery disease, and diabetes.
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J. Thromb. Thrombolysis · Aug 2006
Randomized Controlled TrialExtended-duration thromboprophylaxis in acutely ill medical patients with recent reduced mobility: methodology for the EXCLAIM study.
Venous thromboembolism (VTE) is a significant cause of mortality and morbidity in medical patients. Although thromboprophylaxis with enoxaparin reduces the risk of VTE in these patients, the optimal duration of therapy is not currently known. The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin with the standard regimen of enoxaparin in acutely ill medical patients with recent reduced mobility. ⋯ The EXCLAIM study is designed to show the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin in acutely ill medical patients with recent reduced mobility, which may potentially lead to a reduction in the incidence of late VTE events in these patients. The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study, involving 4,726 acutely ill medical patients with recent reduced mobility, is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using 40 mg once daily enoxaparin (38 +/- 4 days) with the standard regimen for enoxaparin (40 mg once daily for 10 +/- 4 days). The objective of this study is to demonstrate that the extended-duration enoxaparin regimen is an effective and safe thromboprophylaxis regimen out of hospital.