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
© BioMed Central Ltd 2005
Published: 7 March 2005
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.
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).
rFVIIa (n = 24)
Placebo (n = 24)
Total perioperative* blood loss (ml)
Total perioperative blood transfusion requirement (ml)
Salvaged RBC (ml)
Allogeneic RBC (units)
Number of patients transfused with allogeneic blood components
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.