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Critical Care

Open Access

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

  • R Raobaikady1,
  • J Redman2,
  • J Ball3,
  • G Maloney4 and
  • R Grounds1
Critical Care20059(Suppl 1):P338

https://doi.org/10.1186/cc3401

Published: 7 March 2005

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

 

rFVIIa (n = 24)

Placebo (n = 24)

P value

Total perioperative* blood loss (ml)

2070 (431–6774)

1535 (714–7057)

0.79

Intraoperative (ml)

1598 (331–6574)

1188 (514–6657)

0.57

Postoperative (ml)

240 (0–1210)

370 (80–650)

0.022

Total perioperative blood transfusion requirement (ml)

289 (42–2365)

706 (53–7138)

0.33

Salvaged RBC (ml)

194 (0–935)

171 (47–676)

0.90

Allogeneic RBC (units)

0 (0–4)

2 (0–16)

0.34

Number of patients transfused with allogeneic blood components

11 (46%)

16 (67%)

0.24

Data presented as median (range) when applicable. *Perioperative period was defined as the intraoperative period combined with the 48 hours after the first dose of rFVIIa or placebo.

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.

Authors’ Affiliations

(1)
St George's Hospital, London, UK
(2)
York Hospital, York, UK
(3)
Liverpool Hospital, New South Wales, Australia
(4)
Mayo General Hospital, New South Wales, Co Mayo

Copyright

© BioMed Central Ltd 2005

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