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Recombinant activated factor VII (factor VIIa) is a prohemostatic agent that can be used for patients with complicated coagulation disorders. Recombinant factor VIIa is, however, increasingly used for several other indications, including patients with a preexistent normal coagulation system but who experience serious bleeding, for example, after major surgery or trauma.We performed a systematic review of all published and unpublished clinical studies using MEDLINE (1966–2004) and all other sources available to assess the available evidence on the efficacy and safety of recombinant factor VIIa in patients with or without coagulation disorders.We found 483 articles related to the pharmacologic use of recombinant factor VIIa, including 28 clinical trials, 124 case series, and 176 case reports, which were all considered for this review.Recombinant factor VIIa is an effective and relatively potent prohemostatic agent in approximately 90% of patients with hemophilia and inhibiting antibodies and other types of complex coagulation disorders. The application of recombinant factor VIIa in other patients who experience severe bleeding is promising, and although sound evidence from controlled clinical trials is only scarcely available so far, forthcoming trials are likely to provide more substantiation for this use. Recombinant factor VIIa appears to be relatively safe with a 1–2% incidence of thrombotic complications based on published trials.More randomized controlled clinical trials are required to assess the efficacy and safety of recombinant factor VIIa for patients without a preexistent coagulation disorder and with severe bleeding. In the meantime, off-label use of recombinant factor VIIa may be considered in patients with life-threatening bleeding.