Recombinant activated factor VII (rFVIIa) has been successfully used ''off-label'' in patients with refractory life-threatening hemorrhage. Intravenous rFVIIa was given to 31 patients unresponsive to standard therapy with blood products and surgical reexploration, who were bleeding due to trauma, surgery, organ transplantation, liver cirrhosis, ruptured uterus. We recorded their coagulation and hematologic profiles, acid-base balance, blood loss, number of red blood cells (RBC), plasma and platelet transfusions, complications, and survival. rFVIIa (mean dose 132.2 +/- 56.3 microg/kg) effectively contained the hemorrhage in 28/31 (90.3%) cases, with a mean reduction in blood loss from 12.4 +/- 10.2 to 2.7 +/- 2.2 L (P < .0001). The need for RBC, platelet, and plasma transfusion decreased significantly after rFVIIa, with a consequent significant improvement in clotting of test hematocrit, pH, and bicarbonates. Four patients had adverse events potentially related to rFVIIa. The survival rates after 1 and 30 days were 48.4% and 29.1%, respectively.