Background:
The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. we compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy.
Methods:
We enrolled 921 patients with severe acute upper gastrointestinal bleeding and randomly assigned 461 of them to a restrictive strategy (transfusion when the hemoglobin level fell below 7 g per deciliter) and 460 to a liberal strategy (transfusion when the hemoglobin fell below 9 g per deciliter). randomization was stratified according to the presence or absence of liver cirrhosis.
Results:
A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (p<0.001) [corrected].the probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [ci], 0.33 to 0.92; p=0.02). further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (p=0.01), and adverse events occurred in 40% as compared with 48% (p=0.02). the probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% ci, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and child-pugh class a or b disease (hazard ratio, 0.30; 95% ci, 0.11 to 0.85), but not in those with cirrhosis and child-pugh class c disease (hazard ratio, 1.04; 95% ci, 0.45 to 2.37). within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (p=0.03) but not in those assigned to the restrictive strategy.
Conclusions:
As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (funded by fundació investigació sant pau; clinicaltrials.gov number, nct00414713.).