Sep
2004

Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial.

Bosch J, Thabut D, Bendtsen F, et al.
Gastroenterology 2004;127(4):1123-1130.
NATA Rating :
Review by : M. Aldouri
NATA Review

This is a very well designed large international study which studied efficacy and safety of rFVIIa in controlling upper gastrointestinal bleeding in cirrhotic patients. Eight doses of rFVIIa or placebo were given to 242 patients in addition to standard pharmacologic and endoscopic treatment. There was no difference in the overall outcome, but patients with Child-Pugh B and variceal bleeding who received rFVIIa had significantly better response and less failure at 24 hours. There was no significant difference in mortality or side effects. The authors conclude that rFVIIa can be safely used in this clinical setting, and that further studies are required.

– Maadh Aldouri