Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy

Background & Aims: Activated recombinant factor VII (rFVlla) has been shown to be effective in correcting prolonged prothrombin time (PT) in cirrhotic patients. The main objective of this study was to evaluate the effect of 4 (5, 20, 80, and 120 mug/kg) doses of rFVIIa on correction of PT and the time to achieve hemostasis in cirrhotic patients with coagulopathy who are undergoing laparoscopic liver biopsy. Methods: Seventy-one patients (parts I and II) with advanced liver disease (Child-Turcotte B or C), platelet count greater than or equal to60,000/mm(3), and PT in the range Of 3-15 seconds above normal were included in the study. Efficacy endpoints were normalization of PT and time to hemostasis. Results: PT was corrected to normal levels (<13.1 seconds) in the majority of patients. The duration of normalization of PT was longer in patients treated with higher doses of rFVlla. Forty-eight (74%) of 65 patients (part 11) achieved hemostasis within 10 minutes. No correlation between the time to hemostasis and duration of correction of PT was observed. None of the patients required operative intervention or transfusion of blood/blood products to control bleeding. One thrombotic event and one case of disseminated intravascular coagulation were reported, but both events were considered by the investigator as unlikely to be related to treatment with rFVlla. Conclusions: The results of this study suggest that treatment with rFVlla may offer benefit for patients with liver disease undergoing laparoscopic biopsy.