Recombinant activated factor VII (rFVIIa) is considered a universal hemostatic agent. We present our experience with rFVIIa in vascular surgery patients who developed major hemorrhagic complications with no obvious major vessel bleeding as an expansion of the indications of rFVIIa.Of 973 major complex vascular procedures, 18 patients with intractable bleeding were administered 40 to 80 mu g/kg rFVIIa. Blood and by-products transfused, pH, coagulation profile, platelet count, and preoperative antiplatelets and anticoagulants were recorded.Twelve patients (67%) showed clinical improvement. Six remained unstable despite further hemostatic measures and died perioperatively. Thirty-three percent (n = 6) received over 20 U of blood before rFVIIa administration. All but one died within the first 24 hours (p =.0175). Seven patients had acidosis with a pH of 7.3 or less. Five of them died within 24 hours (p =.05). Six patients had a platelet count below 100,000/cm(3), five of whom died perioperatively (p =.0175). Patients with an international normalized ratio above 1.2 had a better survival rate because rFVIIa was used early. There were no signs of systemic or local thrombotic events. The amount of blood and plasma transfused was significantly reduced after rFVIIa administration.rFVIIa is a safe adjunct for patients with significant hemorrhagic! complications, with a low risk of thrombotic complications. We found it effective if administered early with measures to achieve hemodynamic stability and correction of acidosis.