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BJA Advance Access originally published online on September 23, 2005
British Journal of Anaesthesia 2005 95(5):596-602; doi:10.1093/bja/aei244
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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@oxfordjournals.org

CARDIOVASCULAR

Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study

P. Diprose1, M. J. Herbertson1,{dagger}, D. O'Shaughnessy2 and R. S. Gill1,*,{dagger}

1 Department of Anaesthesia and 2 Department of Haematology, Southampton University Hospitals, Tremona Road, Southampton SO16 6YD, UK

* Corresponding author. E-mail: ravi.gill{at}suht.swest.nhs.uk

Background. Receiving an allogeneic transfusion may be an independent predictor of mortality for patients undergoing cardiac surgery. Furthermore, these patients utilize 15% of all donated blood in the UK. In our unit, 80% of patients undergoing complex non-coronary cardiac surgery requiring cardiopulmonary bypass (CPB) receive an allogeneic transfusion. Activated recombinant FVII (rFVIIa) may be effective in reducing this need for transfusion.

Methods. Twenty patients undergoing complex cardiac surgery were randomized to receive rFVIIa or placebo after CPB and reversal of heparin.

Results. Two patients in the rFVIIa group received 13 units of allogeneic red cells and coagulation products compared with eight patients receiving 105 units of allogeneic red cells and coagulation products in the placebo group (relative risk of any transfusion 0.26; confidence interval 0.07–0.9; P=0.037). The groups did not differ for adverse events.

Conclusion. Despite major limitations (underpowered study and prone to type I error), we have shown that rFVIIa significantly reduces the need for allogeneic transfusion in complex non-coronary cardiac surgery without causing adverse events.

{dagger} Declaration of interest. R. S. Gill and M. J. Herbertson undertake consultancy work for NovoNordisk® in the area of clinical trial design and evaluation. The Department of Haematology, Southampton University Hospitals NHS Trust, has received a research grant from NovoNordisk®. The company has had no role in design, execution or interpretation of the studies reported.


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