作者
Jaime Bosch, Dominique Thabut, Flemming Bendtsen, Gennaro D’Amico, Agustín Albillos, Juan González Abraldes, Soeren Fabricius, Elisabeth Erhardtsen, Roberto de Franchis, European Study Group on rFVIIa in UGI Haemorrhage
发表日期
2004/10/1
期刊
Gastroenterology
卷号
127
期号
4
页码范围
1123-1130
出版商
WB Saunders
简介
Background & Aims
Upper gastrointestinal bleeding (UGIB) is a severe and frequent complication of cirrhosis. Recombinant coagulation factor VIIa (rFVIIa) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB. This trial aimed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB.
Methods
A total of 245 cirrhotic patients (Child-Pugh < 13; Child-Pugh A = 20%, B = 52%, C = 28%) with UGIB (variceal = 66%, nonvariceal = 29%, bleeding source unknown = 5%) were randomized equally to receive 8 doses of 100 μg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment. The primary end point was a composite including: (1) failure to control UGIB within 24 hours after first dose, or (2) failure to prevent rebleeding between 24 hours and day 5, or (3) death within 5 days.
Results
Baseline characteristics were similar …
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