Human recombinant activated factor VII for upper gastrointestinal bleeding in patients with liver diseases.

BACKGROUND: Mortality from upper gastrointestinal bleeding in patients with liver disease is high. The human recombinant activated factor VII is one of the suggested treatments for upper gastrointestinal bleeding in these patients.

OBJECTIVES: To assess the beneficial and harmful effects of human recombinant factor VIIa in patients with liver disease and upper gastrointestinal bleeding.

SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, ISI Web of Knowledge, and LILACS. The search strategies used are given in Table 01. We sought additional randomised trials from the reference lists of the trials and reviews identified through the electronic searches.

SELECTION CRITERIA: All randomised clinical trials irrespective of design, publication status, and language comparing human recombinant activated factor VII versus placebo, or any other control intervention for patients with liver disease and upper gastrointestinal bleeding, irrespectively of aetiology.

DATA COLLECTION AND ANALYSIS: We estimated relative risks (RR) for dichotomous outcomes and mean differences for continuous data. Since only one trial was identified, meta-analysis was not possible.

MAIN RESULTS: We included one trial with 242 adult patients. In this study, human recombinant activated factor VII administration did not reduce the risk of death (mortality within five days (RR 1.75, 95% confidence interval (CI) 0.53 to 5.82), and mortality within 42 days (RR 1.45, 95% CI 0.70 to 3.00)).

AUTHORS' CONCLUSIONS: We found no evidence that human recombinant activated factor VII reduces the risk of death in patients with liver disease and upper gastrointestinal bleeding. However, we made our conclusion on a single randomised clinical trial. More randomised clinical trials having low risk of bias are necessary in order to determine the role of human recombinant factor VIIa in clinical practice.