In this European trial, 245 patients with cirrhosis and upper gastrointestinal bleeding were randomised to 8 doses of 100ug/kg of recombinant factor VIIa, or placebo, along with standard medications and endoscopy. The primary outcome combined failure to control bleeding within 24 hours after the first dose, failure to prevent rebleeding between 24 hours and day 5, and death within 5 days.

Addition of the coagulation factor did not significantly improve bleeding outcomes in the overall trial population, but, sub-group analyses on patients with advanced cirrhosis and more severe coagulopathy (Child-Pugh classes B or C) showed significant reductions in failure rates for the composite and 24-hour bleeding control end points than were observed with rFVIIa treatment in the subgroup of variceal bleeders.

No significant differences in mortality or incidence of adverse effects were observed.