title: Transfusion strategies for acute upper gastrointestinal bleeding.
abstract: 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.).
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Autonomous University, Barcelona, Spain. cvillanueva@santpau.cat
authors.forename: Càndid
authors.initials: C
authors.lastname: Villanueva
authors.forename: Alan
authors.initials: A
authors.lastname: Colomo
authors.forename: Alba
authors.initials: A
authors.lastname: Bosch
authors.forename: Mar
authors.initials: M
authors.lastname: Concepción
authors.forename: Virginia
authors.initials: V
authors.lastname: Hernandez-Gea
authors.forename: Carles
authors.initials: C
authors.lastname: Aracil
authors.forename: Isabel
authors.initials: I
authors.lastname: Graupera
authors.forename: María
authors.initials: M
authors.lastname: Poca
authors.forename: Cristina
authors.initials: C
authors.lastname: Alvarez-Urturi
authors.forename: Jordi
authors.initials: J
authors.lastname: Gordillo
authors.forename: Carlos
authors.initials: C
authors.lastname: Guarner-Argente
authors.forename: Miquel
authors.initials: M
authors.lastname: Santaló
authors.forename: Eduardo
authors.initials: E
authors.lastname: Muñiz
authors.forename: Carlos
authors.initials: C
authors.lastname: Guarner
mesh_terms: D000208:Acute Disease; D000328:Adult; D017707:Erythrocyte Transfusion / Q000009:adverse effects / Q000379:methods*; D004932:Esophageal and Gastric Varices / Q000628:therapy; D006471:Gastrointestinal Hemorrhage / Q000097:blood / Q000628:therapy*; D005773:Gastroscopy; D006396:Hematemesis / Q000628:therapy; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008551:Melena / Q000628:therapy
chemical_list: D006454:Hemoglobins