Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy : subgroup analysis from two randomized trials
Date
2006-12
Authors
Rizoli, Sandro B.
Boffard, Kenneth D.
Riou, Bruno
Warren, Brian
Iau, Philip
Kluger, Yoram
Rossaint, Rolf
Tillinger, Michael
NovoSeven Trauma Study Group
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
Introduction: We conducted a post-hoc analysis on the effect of recombinant factor VIIa (rFVIIa) on coagulopathic patients from two randomized, placebo-controlled, double-blind trials of rFVIIa as an adjunctive therapy for bleeding in patients with severe trauma. Methods: Blunt and penetrating trauma patients were randomly assigned to rFVIIa (200 + 100 + 100 μg/kg) at 0, 1, and 3 hours after transfusion of 8 units of red blood cells (RBCs) or to placebo. Subjects were monitored for 48 hours post-dosing and followed for 30 days. Coagulopathy was retrospectively defined as transfusion of fresh frozen plasma (FFP) (>1 unit of FFP per 4 units of RBCs), FFP in addition to whole blood, and transfusion of platelets and/or cryoprecipitate. Results: Sixty rFVIIa-treated and 76 placebo subjects were retrospectively identified as being coagulopathic. No significant differences were noted in baseline characteristics. The rFVIIa-treated coagulopathic subgroup consumed significantly less blood product: RBC transfusion decreased by 2.6 units for the whole study population (P = 0.02) and by 3.5 units among patients surviving more than 48 hours (P < 0.001). Transfusion of FFP (1,400 versus 660 ml, P < 0.01), platelet (300 versus 100 ml, P = 0.01), and massive transfusions (29% versus 6%, P < 0.01) also dropped significantly. rFVIIa reduced multi-organ failure and/or acute respiratory distress syndrome in the coagulopathic patients (3% versus 20%, P = 0.004), whereas thromboembolic events were equally present in both groups (3% versus 4%, P = 1.00). Conclusion: Coagulopathic trauma patients appear to derive particular benefit from early adjunctive rFVIIa therapy.
Description
Keywords
Recombinant factor VIIa (rFVIIa), Bleeding in patients with severe trauma, Hemorrhagic shock
Citation
Rizoli, SB, Boffard, KD, Riou, B, Warren, B, Lau, P, Kluger, Y, Rossaint, R, Tillinger, M & NovoSeven® Trauma Study Group 2006, 'Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials', Critical Care, 10(6):R178.