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BJA Advance Access published online on February 25, 2005
British Journal of Anaesthesia, doi:10.1093/bja/aei102
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© The Board of Management and Trustees of the British Journal of Anaesthesia 2005. All rights reserved. For Permissions, please e-mail: journal.permissions@oupjournals.org
Accepted January 21, 2005

Clinical Investigation

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{dagger}{ddagger}

R. Raobaikady 1, J. Redman 1, J. A. S. Ball 1, G. Maloney 1, and R. M. Grounds 1*

1 Department of Anaesthesia and Intensive Care, St George's Hospital, London, UK

* To whom correspondence should be addressed.
R. M. Grounds, E-mail: michael.grounds{at}stgeorges.nhs.uk


  Abstract

Background. 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, randomized, placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery. Patients were randomized to receive an i.v. bolus injection of rFVIIa 90 µg kg-1 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. 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.

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.

Keywords: blood, coagulation, recombinant FVIIa; blood, loss; surgery, repair of traumatic, pelvic-acetabular fracture.

{dagger} This article is accompanied by the Editorial.

{ddagger} Declaration of interest. R. M. Grounds has worked in the past as a consultant for Novo Nordisk and has lectured at symposiums organized by Novo Nordisk. Novo Nordisk has given an unrestricted educational grant to St George's Hospital Special Trustee's. The trial was funded by Novo Nordisk, UK.


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