The use of activated recombinant coagulation factor VII in patients undergoing major reconstruction surgery for traumatic fracture pelvis or pelvis and acetabulum: a double-blind, randomised, placebo-controlled trial

Introduction

Activated recombinant coagulation factor VII (rFVIIa) effectively prevents and controls bleeding in patients with coagulopathy. Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery. We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum, who were expected to have a large volume of blood loss.

Methods

We performed a double-blind, randomised, placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery. Patients were randomised to receive an intravenous bolus injection of 90 μg/kg rFVIIa or placebo as add-on therapy at the time of the first skin incision. All patients also received intraoperative salvaged red blood cells (RBC).

Results

There was no significant difference in the total volume of perioperative blood loss, the primary outcome variable, between the rFVIIa and placebo groups (Table 1). In addition, there were no differences between the two groups in the total volume of blood components including salvaged RBC transfused, number of patients requiring allogeneic blood components, total volume of fluids infused, total operating time, time taken after entry to the intensive care unit to reach normal body temperature and acid-base status, and time spent in hospital. No adverse events, in particular thromboembolic events, were reported in either group.

Table 1 Trial results

Conclusions

In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture, the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss. Nevertheless, the use of rFVIIa appears to be safe in this patient population.