Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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Clin. Appl. Thromb. Hemost. · Nov 2018
Randomized Controlled Trial Multicenter StudyEfficacy and Safety of a Biosimilar Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: A Randomized, Prospective, Single-Blinded, Multicenter Clinical Trial.
Several biosimilar versions of enoxaparin are already approved and in use globally. Analytical characterization can establish good quality control in manufacturing, but they may not assure similarity in clinical outcomes between biosimilar and branded enoxaparin. This study evaluated the efficacy and safety of biosimilar Cristália versus branded Sanofi enoxaparin in venous thromboembolism (VTE) prevention in patients undergoing major abdominal surgery at risk for VTE. ⋯ The incidence of VTE was 4.9% in the Cristália group and 1.1% in the Sanofi group (absolute risk difference = 3.80%, 95% confidence interval [CI]: -1.4%-9.0%) yielding noninferiority since the 95% CI does not reach the prespecified value Δ = 20%. Clinically significant bleeding occurred in 9.9% in the Cristália group and in 5.5% in the Sanofi group (n.s. ). In conclusion, this study suggests that 40 mg once daily of Ce, a biosimilar enoxaparin, is as effective and safe as the branded Sanofi enoxaparin in the prophylaxis of VTE in patients submitted to major abdominal surgery at risk for VTE.
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Clin. Appl. Thromb. Hemost. · Mar 2015
Randomized Controlled Trial Multicenter Study Comparative StudyDysregulation of inflammatory and hemostatic markers in sepsis and suspected disseminated intravascular coagulation.
Inflammatory mediators and hemostatic markers were evaluated in patients enrolled in a phase-2b study evaluating the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with sepsis and suspected disseminated intravascular coagulation (DIC). In contrast to controls, patients with sepsis and suspected DIC showed an increase in the circulating levels of inflammatory and fibrinolytic markers. ⋯ When the patients with overt and nonovert DIC were compared, the PrC level was lower, and PCT, PAI-1, IL-6, and IL-10 levels were higher in the patients with overt DIC. These results indicate that inflammation is elevated in sepsis and suspected DIC, and inflammation, impairment of fibrinolysis, and overconsumption of PrC may play a key role in the pathogenesis of DIC.
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Clin. Appl. Thromb. Hemost. · Apr 2014
Randomized Controlled TrialProtamine overdose and its impact on coagulation, bleeding, and transfusions after cardiopulmonary bypass: results of a randomized double-blind controlled pilot study.
We assessed the effects of protamine overdosing on thrombelastometry, bleeding, and transfusions in patients after cardiopulmonary bypass (CPB). ⋯ Heparin dose-based protamine management leads to protamine overdosing with inhibition of the coagulation process. Protamine management guided by heparin concentration avoids these complications.
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Clin. Appl. Thromb. Hemost. · Mar 2014
Randomized Controlled Trial Multicenter StudyThrombin generation mediators and markers in sepsis-associated coagulopathy and their modulation by recombinant thrombomodulin.
Severe sepsis remains the most common cause of death in critically ill patients, and thrombin plays a crucial role in the pathogenesis of sepsis-associated disseminated intravascular coagulation (DIC). The purpose of this study was to profile prothrombin fragment (F1.2), thrombin-antithrombin complex (TAT), and d-dimer (DD) throughout the course of hospital stay in patients identified with sepsis. Plasma samples from patients enrolled in the ART-123 study, a phase 2b, international, multicenter, randomized placebo-controlled trial were analyzed for various parameters using enzyme-linked immunosorbent assay methods. ⋯ Although the data were widely scattered, these results show that DIC represents a hypercoagulable state along with other hemostatic abnormalities and the activation of the inflammatory process. Modulation of these activation processes through targets such as DD, F1.2, and TAT may play an important regulatory role in the pathogenesis of sepsis-associated coagulopathy. Moreover, this study validates the hypothesis that thrombomodulin downregulates the thrombin generation mediators/markers in sepsis-associated DIC.
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Clin. Appl. Thromb. Hemost. · Sep 2012
Randomized Controlled TrialA randomized controlled trial on the hemostasis of femoral artery using topical hemostatic agent.
Evaluation of the effect of using a topical hemostatic agent named "ChitoHem(®)" on different factors on patients undergoing diagnostic coronary angiography. ⋯ It was exhibited ChitoHem(®) topical hemostatic powder used on treatment patients undergoing diagnostic coronary angiography was statistically superior at reducing the time to hemostasis and ambulation as well as the use of sandbags compared with manual compression in control group.