Recombinant activated factor seven (rFVIIa) is a novel and emerging therapy for the acquired coagulopathy associated with massive bleeding and hemorrhagic shock. The intent of this paper is to review the mechanism of action of rFVIIa, to discuss the current state of evidence regarding the safety and efficacy of rFVIIa, and to offer guidance regarding its use in severely traumatized patients. No study has demonstrated a survival benefit in humans. rFVIIa, is safe to use in the setting of severe trauma associated with ongoing bleeding and acquired coagulopathy. Doses of 80—200 μg/kg may be used after correction of thrombocytopenia and acidosis. Hypothermia should be corrected in any traumatized patient, but should not be a barrier to its administration. Definitive evidence supporting the use of rFVIIa is lacking, but ongoing studies will delineate survival benefits, dosing regimens, and adverse events associated with its use.
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