Safety and efficacy of recombinant activated factor VII in nonhemophilia children with severe or life-threatening bleeding: a report from the SeveNBleeP registry

Abstract

We evaluated efficacy and safety of recombinant activated factor VII (rFVIIa) in nonhemophilia children with life-threatening or severe bleeding. Using data from the SeveNBleeP registry, we analyzed demographic, clinical, laboratory, and treatment data for children who received rFVIIa to treat severe hemorrhage. The SeveNBleeP registry was international registry formed in 2005, to collect information on the use of rFVIIa in the off-label setting of severe bleeding in nonhemophilia patients. There were 191 patient records entered into this registry, of which 164 were validated. Of the 164 records, in 137 patient records, rFVIIa was used for treatment of bleeding episodes. Of these 137 treatme..