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Review

Efficacy and Safety of Recombinant Activated Factor VII to Control Bleeding in Nonhemophiliac Patients: A Review of 17 Randomized Controlled Trials

^a Department of Anesthesiology, University of Montreal, Université Libre de Bruxelles, Montreal, Quebec, Canada
^b Department of Anesthesiology, CHU Brugmann, Université Libre de Bruxelles, Belgium, Germany

^_* Address correspondence to Dr Hardy, Département d'anesthésiologie, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Pavillon Lachapelle-Porte AS-1115-3, 1560 rue Sherbrooke est, Montréal, Québec, H2L 4M1, Canada (Email: jean-francois.hardy{at}umontreal.ca).

We reassess all published randomized controlled trials that have evaluated the hemostatic efficacy or safety of recombinant activated factor VII (rFVIIa), or both, in nonhemophiliac patients. Seventeen trials published in 16 articles dealt either with the prophylactic (nine trials) or the therapeutic (eight trials) use of rFVIIa to prevent or to treat excessive bleeding. At present, the role of rFVIIa to prevent or to control bleeding and reduce transfusions in various patient populations remains unclear. In addition, the safety of rFVIIa remains a concern. Consequently, we conclude that the generalized use of rFVIIa to prevent or to control bleeding in nonhemophiliac patients can not be recommended.

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