This is an informative single institution study comparing the outcome of 51 patients who received rFVIIa (2.4 or 4.8 mg) for severe bleeding following cardiac surgery with matched controls. All patients initially received standard therapy with blood products and antifibrinolytics. RFVIIa was administered following clinical guidelines related to blood loss and blood transfusion. Twenty patients required re-explorative surgery, identifying surgical cause for blood loss in 8. There was significant reduction in blood loss and transfusion requirement in the treatment group. RFVIIa treated patients had a longer ICU and hospital stay, as well as a higher incidence of renal dysfunction and a trend toward a higher incidence of stroke, but there were clear predisposing factors for 3 out of 4 patients in the rFVIIa group who suffered with stroke. However, the results are very encouraging in such a difficult group of patients, emphasizing the need for large randomized studies.

– Maadh Aldouri