Recombinant activated factor VII in cardiac surgery

Adult cardiac surgery has an incidence of 1–1.25 million procedures per year. Overall costs are in the range of US$50 billion per year and are increasing. Included in these costs is an increasing burden from the use of blood and blood products. The central haemostatic problems associated with cardiac surgery are impaired platelet function associated with pre-operative medication and cardiopulmonary bypass, consumption of platelets, dilution of coagulation proteins and triggering of fibrinolysis. Anecdotal data suggest that recombinant activated factor VII (rFVIIa) has a possible role in cardiac surgery, but randomized, controlled trials are required to confirm this potential. We have undertaken a prospective, randomized, placebo-controlled trial in adult cardiac surgery with a high risk of serious haemorrhage. Drug (rFVIIa) or placebo is given after cardiopulmonary bypass and following the administration of protamine. The primary endpoints of the study are use of blood and blood products. Secondary endpoints are blood loss, length of stay in the intensive care unit and in the hospital, and survival. This study will give us further information on the potential efficacy and safety of rFVIIa in cardiac surgery.