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Recombinant factor VIIa

About: Recombinant factor VIIa is a research topic. Over the lifetime, 1682 publications have been published within this topic receiving 51363 citations.


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Journal ArticleDOI
TL;DR: Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma and the safety of rFVIIa was established in these trauma populations within the investigated dose range.
Abstract: Background: Uncontrolled bleeding is a leading cause of death in trauma. Two randomized, placebo-controlled, double-blind trials (one in blunt trauma and one in penetrating trauma) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor Vila (rFVIIa) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Methods: Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 μg/kg) or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell (RBC) unit, with additional doses 1 and 3 hours later. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose. Results: Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups. Conclusion: Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range.

730 citations

Journal ArticleDOI
TL;DR: It is reported that factor VIIa bound weakly to activated platelets and could initiate thrombin generation in the presence of plasma concentrations of prothrombin, factor X, factor V, antithrombin III and tissue factor pathway inhibitor.
Abstract: High-dose recombinant factor VIIa has been successfully used as therapy for haemophiliacs with inhibitors. The mechanism by which high-dose factor VIIa supports haemostasis is the subject of some controversy. Postulating a mechanism in which activity is dependent on tissue factor at the site of injury explains the localization of activity but not the requirement for high doses. Postulating a mechanism in which factor VIIa acts on available lipid independently of tissue factor explains the requirement for high doses but not the lack of systemic procoagulant activity. We report that factor VIIa bound weakly to activated platelets (Kd approximately 90 nM). This factor VIIa was functionally active and could initiate thrombin generation in the presence of plasma concentrations of prothrombin, factor X, factor V, antithrombin III and tissue factor pathway inhibitor. The activity was not dependent on tissue factor. The concentration of factor VIIa required for detectable thrombin generation agreed well with the lowest concentration of factor VIIa required for efficacy in patients. High-dose factor VIIa may function on the activated platelets that form the initial haemostatic plug in haemophilic patients. These observations are in agreement with clinical trials which have shown that high-dose factor VIIa was haemostatically effective without causing systemic activation of coagulation.

552 citations

Journal ArticleDOI
TL;DR: Administration of recombinant factor VIIa immediately corrected the coagulopathy and bleeding stopped and surgery failed to stop life-threatening bleeding caused by injury complicated by severe coagULopathy.

470 citations

Journal ArticleDOI
15 Jan 2007-Blood
TL;DR: FEIBA and NovoSeven appear to exhibit a similar effect on joint bleeds, although the efficacy between products is rated differently by a substantial proportion of patients.

416 citations

Journal ArticleDOI
TL;DR: An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery.

415 citations


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Performance
Metrics
No. of papers in the topic in previous years
YearPapers
202316
202241
202128
202031
201923
201830