Use of Recombinant Activated Factor VII to Arrest Uncontrolled Bleeding: A Case Series

Abstract

A retrospective analysis is described to assess the effects of using recombinant activated factor VII to control bleeding in a series of patients who had failed to respond to conventional hemostatic measures. In all, 18 patients (aged 16-65 years) with a range of conditions resulting in bleeding refractory to conventional methods of control were treated with recombinant activated factor VII (60-120 Amicrog/kg; 1-4 doses). The effects of recombinant activated factor VII on bleeding were noted together with the patients' transfusion requirements and hematological parameters. Administration of recombinant activated factor VII successfully stopped bleeding in 17 of the 18 patients. Therapy with recombinant activated factor VII significantly decreased transfusion requirements for packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate compared with pretreatment values along with significant improvement in hemostasis. In various serious bleeding situations, treatment with recombinant activated factor VII may effectively arrest bleeding, which has remained refractory to conventional methods of control.

Recombinant factor VIIa as last‐resort treatment of desperate haemorrhage

“…After the report of successful use of rFVIIa in a patient suffering massive haemorrhage from a gunshot wound in 1999, rFVIIa has been used for various off‐label indications. Numerous case reports have been published as well as single institution case series on its use in critical non‐haemophilic bleeding, clinical observational studies in refractory bleeding and randomized clinical trials (RCTs) on bleeding in major cardiac surgery and in multitrauma . Although most studies have reported reduced bleeding or reduced transfusion requirement following administration of rFVIIa, three recent meta‐analyses on off‐label use have come to conflicting conclusions on mortality in massive haemorrhage, and concerns with increased arterial thromboembolic risk have been raised .…”