Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study.
Cardiac surgery is often associated with excessive blood component transfusion especially with complex and repeat procedures, and is therefore an obvious target for blood saving measures. There have been several previous case reports and small nonrandomized studies reporting efficacy and safety of rFVIIa in controlling severe intra- and postoperative bleeding with cardiac surgery, but this is an important randomized study which confirmed previous observations. Twenty patients were randomized to receive either rFVIIa or placebo after CPB and reversal of heparin, and there was a very significant increase in red cell transfusion and coagulation products in the placebo group. All patients received standard care such as red cell salvage and aprotinin as appropriate. The authors admit to some limitations such as the small number of patients which rendered the study underpowered and prone to type I error, as well as lack of transfusion protocol after CPB, nevertheless the results strongly confirm the efficacy of rFVIIa in this patient group and justifies further and larger studies in this area, in addition to weighing the potential benefits with the high cost of therapy.
– Maadh Aldouri