The effect of recombinant factor VIIa (rFVIIa) on blood loss was evaluated in cirrhotic patients undergoing orthotopic liver transplantation. In the present study, we explored the effect of rFVIIa on coagulation and fibrinolysis during orthotopic liver transplantation. Coagulation factors, parameters of thrombin generation and parameters of fibrinolysis were measured in six patients who had received a single dose of 80 micro g/kg rFVIIa and in ten controls, during and after orthotopic liver transplantation. Baseline concentrations and course of coagulation factors were similar in patients and controls. Thrombin generation did not rise after the administration of rFVIIa, but showed a sharp increase after reperfusion in patients, as compared with controls. No difference in fibrinolysis was apparent between patients and controls. No evidence of diffuse intravascular coagulation was seen. We conclude that the use of rFVIIa in orthotopic liver transplantation seems to enhance thrombin generation in a localized and time-limited matter, without causing systemic coagulation.