Clinical experiences with recombinant activated factor VII for managing uncontrolled hemorrhage in non-hemophilic patients

Objective: Recombinant activated factor VII (rFVIIa) is a novel hemostatic agent originally developed to treat hemophilia patients who had developed inhibitors with bleeding. Its role in treating uncontrolled bleeding in patients without pre-existing coagulation abnormalities has not been well established. We herein report our experiences with its use in non-hemophilic patients. Patients and Methods: Four patients, aged 33 to 94 years, with different underlying diseases were treated with rFVIIa for uncontrolled, life-threatening hemorrhage. rFVIIa was initially administered by intravenous bolus injection at 80-100 μg/kg. Doses were adjusted according to clinical response. Results: Clinical response with significant hemostasis was evident in three patients after initial treatment. One patient was unresponsive to rFVIIa treatment and died of uncontrolled bleeding. Of those who achieved initial hemostasis, two died of their underlying diseases. One had recurrent bleeding controlled by subsequent multiple doses of rFVIIa, but she died of acute myocardial infarction, a thromboembolic complication that probably arose from the use of rFVIIa. Conclusion: Our results suggest that rFVIIa could play a role in the management of bleeding other than congenital coagulation disorder. However, clinical hemostatic effects that do not translate into a survival benefit require further study, especially with regard to appropriate timing for clinical use. Its potential risk, especially that of thromboembolism when treating bleeding in elderly patients, warrants further investigation.