Transfusion strategies for acute upper gastrointestinal bleeding
Villanueva 2013 trial design and results
Design
Randomised controlled trial
Treatment
Restrictive strategy, transfusion at haemoglobin below 7 g/dL
Control
Liberal strategy, transfusion at haemoglobin below 9 g/dL
Population
921 patients with acute upper gastrointestinal bleeding
Follow-up
45 days
Primary endpoint
Death from any cause within 45 days
Result
225 patients assigned to the restrictive strategy (51%) received no transfusion versus 61 (14%) in the liberal group (p<0.001). Survival at 6 weeks was 95% versus 91% (hazard ratio for death 0.55, 95% CI 0.33 to 0.92, p=0.02); further bleeding 10% versus 16% (p=0.01); adverse events 40% versus 48% (p=0.02). The survival benefit was significant in Child-Pugh A or B cirrhosis (hazard ratio 0.30, 95% CI 0.11 to 0.85) but not in Child-Pugh C (1.04, 0.45 to 2.37) or peptic ulcer bleeding (0.70, 0.26 to 1.25).
Secondary endpoints
Rebleeding, adverse events, complications of transfusion
As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding.
The trial authors, in the published abstract
How it has aged
One of the few transfusion trials where restriction actively helps rather than merely proving non-inferior — plausibly because transfusion raises portal pressure and provokes rebleeding in variceal disease. The benefit did not extend to Child-Pugh C cirrhosis, so the threshold should not be applied mechanically to the most decompensated patients, nor to exsanguinating haemorrhage, which the trial excluded. Contrast the brain injury and myocardial infarction trials, where restriction is at best neutral.
Publications
Transfusion strategies for acute upper gastrointestinal bleeding
Villanueva C, Colomo A, Bosch A, et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med 2013 Jan 3;368(1):11-21.
Improved survival with the restrictive strategy
Less rebleeding
Half the restrictive group received no transfusion at all