Usefulness of activated recombinant factor VII for controlling massive bleeding: 4 years' experience in a university hospital

OBJECTIVE: Massive bleeding that cannot be controlled by the usual means, such as transfusion, is a serious medical problem with high associated mortality. Our aim was to assess the efficacy and safety of treatment with activated recombinant factor VII (rFVIIa) to control massive bleeding after the failure of other methods. PATIENTS AND METHODS: This was a retrospective study of all cases of rFVIIa-treated massive bleeding in patients without a history of coagulation disorder from January 2003 through June 2007. RESULTS: The prevalence of rFVIIa treatment for this indication was 1 in 5200 hospitalized patients. Thirty patients were treated. Bleeding was reduced or stopped in 80% and consumption of blood products was reduced after administration of rFVIIa. Mortality was 43% and death was due to continued bleeding in 5 cases. No deaths were due to thromboembolism. CONCLUSIONS: rFVIIa is efficacious for controlling bleeding and reducing transfusion requirements in cases of massive hemorrhage, but mortality unrelated to bleeding is high in patients experiencing this complication. Further study is needed to better assess the utility, dosing, and ideal timing in the use of this drug.