Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials

ABSTRACT: 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 randomized to rFVIIa (200 + 100 + 100 ìg/kg) at 0, 1, and 3 hours after transfusion of 8 units of red blood cells (RBC), 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 FFP per 4 units RBC); FFP in addition to whole blood; transfusion of platelets and/or cryoprecipitate. RESULTS: 60 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 products: RBC transfusion decreased by 2.6 units for the whole study population (P=0.02) and by 3.5 units among patients surviving >48 hours (P<0.001). Transfusion of FFP (1400ml versus 660ml, P<0.01), platelet (300ml versus 100ml, 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) while thromboembolic events were equally present in both groups (3% versus 4%, P=1.00). CONCLUSIONS: Coagulopathic trauma patients appear to derive particular benefit from early adjunctive rFVIIa therapy