Efficacy of recombinant activated Factor VII in patients with massive uncontrolled bleeding: a retrospective observational analysis

Abstract

Background: Recombinant activated Factor VII (rFVIIa) is a prohemostatic agent used for treatment of hemophilia patients with inhibiting antibodies. It has also been used in the context of massive uncontrolled blood loss, but the efficacy has not been proven. The aim of this study was to evaluate the effectiveness of rFVIIa in massive uncontrolled blood loss.

Study design and methods: In this retrospective observational analysis patients were included that had received rFVIIa between April 2004 and January 2008 in the context of bleeding that could not be controlled by conventional transfusion therapy. Data were retrieved from patient files, anesthesia reports, the electronic hospital information system, and the computer files of the hospital blood transfusion service. Baseline demographics, medication data, laboratory data, transfusion data, and surgical data were analyzed.

Results: In 32 patients with massive uncontrolled blood loss, a significant reduction in transfusion requirements was observed after infusion of rFVIIa, when comparing the transfusions before and up to 48 hours after infusion of rFVIIa. Mean red blood cell (RBC) transfusions showed a reduction of 20.1 units before rFVIIa to 8.7 after rFVIIa (mean difference, 11.4 units; 95% confidence interval [CI], 6.4-16.5) and fresh-frozen plasma (FFP) transfusions showed a reduction of 19.3 units before rFVIIa to 9.3 after rFVIIa (mean difference, 9.9 units; 95% CI, 4.2-15.6). Fifty-six percent of patients receiving rFVIIa for uncontrolled life-threatening bleeding were alive at discharge from the hospital.

Conclusion: This study suggests that rFVIIa may play a role in patients with massive uncontrolled blood loss by reducing the amount of RBC and FFP transfusions and by improving the coagulation variables.