Efficacy and safety of recombinant activated factor VII to control bleeding in nonhemophiliac patients: a review of 17 randomized controlled trials.

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.