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

Background. Activated recombinant coagulation factor VII (rFVIIa)effectively prevents and controls bleeding in patients withcoagulopathy. Data show that rFVIIa may reduce blood loss andeliminate the need for transfusion in patients with normal haemostasisundergoing major surgery. We assessed the efficacy of rFVIIain patients with normal haemostasis undergoing repair surgeryof major traumatic fracture of the pelvis or the pelvis andacetabulum, who were expected to have a large volume of bloodloss. Methods. We performed a double-blind, randomized, placebo-controlledtrial involving 48 patients undergoing major pelvic–acetabularsurgery. Patients were randomized to receive an i.v. bolus injectionof rFVIIa 90 µg kg^–1 or placebo as add-on therapyat the time of the first skin incision. All patients also receivedintraoperative salvaged red blood cells (RBC). Results. There was no significant difference in the total volumeof perioperative blood loss, the primary outcome variable, betweenthe rFVIIa and placebo groups. In addition, there were no differencesbetween the two groups in the total volume of blood components,including salvaged RBC transfused, number of patients requiringallogeneic blood components, total volume of fluids infused,total operating time, time taken after entry to the intensivecare unit to reach normal body temperature and acid–basestatus, and time spent in hospital. No adverse events, in particularthromboembolic events, were reported in either group. Conclusions. In patients with normal haemostasis undergoingrepair surgery of traumatic pelvic–acetabular fracture,the prophylactic use of rFVIIa does not decrease the volumeof perioperative blood loss.