Recombinant Factor VIIa for Life-Threatening Hemorrhage in Trauma Patients: Review of the Literature

Abstract The control of hemorrhage and coagulopathy is a vital component of trauma care, and failure to achieve hemostasis can contribute to mortality. Recombinant factor VIIa (rFVIIa) is a well-established therapy for bleeding episodes and surgical prophylaxis in hemophilia patients with inhibitors. However, there has been increasing utilization of rFVIIa in the treatment of trauma-related blood loss in patients without pre-existing coagulopathy. This paper reviews published experience in this area. Database searches identified 126 rFVIIa-treated trauma patients reported in 15 publications between November 1999 and November 2004. Ages ranged from 20 months to 88 years, and the majority of patients (68.7%) had suffered blunt injury. In most cases, rFVIIa was used as a salvage therapy when bleeding continued despite the appropriate application of available conventional hemostatic methods. Doses of rFVIIa varied widely (36–178 μg/kg), with patients receiving a single dose or multiple doses separated by an interval of 2–12 h. Efficacy of treatment (reduction in blood loss, transfusion requirements and mortality) was reported for 79.4% of subjects. Most publications also described shortening or normalization of coagulation parameters following rFVIIa administration. No non-thrombotic adverse events were noted in any patient, but five cases (4.0%) of thromboembolic events were recorded. Recently reported clinical trial data offer support to these anecdotal observations. In conclusion, data appear to support the utility of rFVIIa as an adjunctive therapy for the reduction of hemorrhage and transfusion requirements in trauma patients. However, further information relating to the use of rFVIIa in the trauma setting is required.