Recombinant activated factor VII for the treatment of bleeding in abdominal surgery and cardiac surgery

Introduction

Recombinant activated factor VII (rFVIIa) plays a key role in hemostasis. The aim of this study was the clinical evaluation of the efficacy of rFVIIa in the treatment of bleeding during and after abdominal and cardiac surgery.

Methods

A meta-analyses of case-series studies (n = 67) on the treatment of bleeding with rFVIIa regarding reduction or cessation of bleeding and mortality. We used the questioners of Novo Nordisk to assess the indications and effectiveness of treatment. We compared the amount of blood loss within 12 hours before and within 12 hours after giving rFVIIa, and the dynamics of bleeding. In 10 patients the bleeding started after surgery intraoperatively, in 57 patients severe hemorrhage developed in the postoperative period. We also compared the full blood count and laboratory coagulation profile parameters before treatment, and 2 and 12 hours after treatment. In cardiac surgery rFVIIa was administered 5 to 49 minutes after neutralization of heparin with protamine sulfate. The dosage of rFVIIa was 39.23 ± 20.70 μ/kg We used Student's t test for statistical analysis.

Results

After administration of the first median dose (14.45 to 81.35 μg/kg) of rFVIIa, bleeding stopped in 47 patients. Bleeding was markedly decreased in 15 patients. Five patients who did not benefit from initial rFVIIa administration received additional drug in a dose of 38.25 μg/kg with good results. The average blood loss within 12 hours before treatment was 2,510.00 ± 1,642.07 ml, and the average blood loss within 12 hours after treatment was 1,057.75 ± 810.67 ml. The average dynamics of bleeding before treatment were 216.35 ± 138.82 ml/hour, and 87.90 ± 67.82 ml/hour after treatment. Transfusion requirements were reduced for packed red blood cells, fresh frozen plasma, platelets, and crystalloid and/or colloids. Reduction in transfusion requirements was statistically significant (P ≤ 0.05).

Conclusion

The meta-analysis of case series showed that in a mean of 85% patients rFVIIa achieved at least a reduction of bleeding, reducing the need for hemotransfusions.