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

Sandro B. Rizoli, Kenneth D. Boffard, Bruno Riou, Brian L. Warren, Philip Iau, Yoram Kluger, Rolf Rossaint, Michael Tillinger, A. Nicol, R. Tracey, J. S.S. Marx, E. Degiannis, J. Goosen, F. Plani, L. M. Fingleson, J. F. Payen de La Garanderie, J. Marty, R. Krivosic-Horber, M. Freysz, J. E. de La CoussayeJ. Duranteau, B. Francois, N. Smail, P. Petit, H. K. van Aken, G. Hempelmann, A. I. Rivkind, G. Shaked, M. Michaelson, P. Iau Tsau Choong, A. Yeo Wan Yan, S. M. Hameed, G. S. Samra, G. J. Dobb

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67 Scopus citations

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.

Original languageEnglish
Article numberR178
JournalCritical Care
Volume10
DOIs
StatePublished - 1 Jan 2006

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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