A 47-year-old man presents with hypovolemic shock. He takes warfarin as a result of a mechanical mitral valve insertion 5 years prior, his INR at presentation is 8.4 and emergent CT reveals a very large retroperitoneal hematoma. Despite aggressive fluid and transfusion support he continues hypotensive, requiring ionotrope support. You are asked if he should receive recombinant factor VIIa.To examine current best evidence of the effect of recombinant factor VIIa (rFVIIa) on the reversal of warfarin-induced coagulopathy, we performed a comprehensive computerized literature search of the OVID database using the terms warfarin (MESH, no restrictions, 13764 hits), AND recombinant factor VIIa (MESH, including factor VII, factor VIIa, and recombinant FVIIa, 5928 hits), AND reversal (MESH, no restrictions, 39639 hits) OR correction (MESH, no restrictions, 72783 hits) between 1950 and week 2 May 2008. This strategy provided 22 hits. There were 4 additional studies gleaned from the reference list of 2 of the articles. 1-4 Twelve papers were excluded: 7 were review articles, 5-11 3 described effects of clotting factor concentrates or vitamin K and not rFVIIa, 12-14 1 compared the in vitro antifibrinolytic activity of prothrombin complex concentrates to rFVIIa, 15 and 1 was a case report of rFVIIa in a phenindione overdose. 16 Five case series, 5 case reports, 1 retrospective casecontrol, 1 retrospective chart review, and 1 database review were retrieved. There was also 1 study involving healthy volunteers that included a dose finding study followed by a randomized controlled trial.The randomized double-blind placebo controlled trial was a pharmacokinetic-pharmacodynamic study of 28 healthy volunteers given acenocoumarol followed by rFVIIa (doses ranging from 5 to 320 μg/kg). The dose finding aspect of the study revealed that a single dose of 5 μg/kg normalized the INR for 12 hours and doses >120 μg/kg normalized the INR for 24 hours. The placebo had no effect on the INR. 2