Undoubtedly, there is a clinical need for one or more newhemostatic agents to supplement a limited armamentarium oftherapeutic options for bleeding that cannot be controlled bysurgical intervention, local hemostatic agents and transfusion ofblood products. Recombinant activated factor VII has been approved by the U.SFood and Drug Administration (FDA) for nearly a decade for theprevention and treatment of bleeding episodes in hemophilicpatients with inhibitors to coagulation factor VIII or factor IX. Anincreasing number of case series and reports have described itsefficacy in controlling massive hemorrhage.