Audit of factor VIIa for bleeding resistant to conventional therapy following complex cardiac surgery.

PURPOSE There are an increasing number of anecdotal reports and trials of recombinant activated factor VII (rFVIIa) for bleeding during surgery. The reports of rFVIIa during cardiac surgery are limited. We report our experience using rFVIIa, in the operating room; to treat bleeding that prevented chest closure, despite appropriate conventional treatment, following complex cardiac surgery. METHODS Retrospective chart review, at an Australian University hospital and associated private hospital, of cardiac surgery patients given rFVIIa (usual dose 90 microg.kg(-1)). We used rFVIIa for bleeding that prevented closure of the chest despite administration of blood products, protamine, and surgical attempts to secure hemostasis. RESULTS Recombinant activated factor VII was administered on 55 occasions to 53 patients. Most patients had complex aortic or valve surgery. Median bypass time was 266 min. Before administering rFVIIa, patients received (median): packed red cells four units; platelets 15 units; fresh frozen plasma eight units; and cryoprecipitate ten units. After administering rFVIIa the median doses of donor blood products up to 12 hr after intensive care unit admission were: packed red cells one unit; platelets zero units; fresh frozen plasma zero units; and cryoprecipitate zero units. The decrease in doses of all blood products was significant (P < 0.001). We could not determine if rFVIIa played a role in significant mortality (19%) and morbidity (17%). CONCLUSION Use of rFVIIa in cardiac surgery may be effective, but definitive clinical trials are needed to clarify its role in clinical practice and safety. We present an rFVIIa guideline developed during the audit period.