Document Detail


Transfusion strategies for acute upper gastrointestinal bleeding.
MedLine Citation:
PMID:  23281973     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Càndid Villanueva; Alan Colomo; Alba Bosch; Mar Concepción; Virginia Hernandez-Gea; Carles Aracil; Isabel Graupera; María Poca; Cristina Alvarez-Urturi; Jordi Gordillo; Carlos Guarner-Argente; Miquel Santaló; Eduardo Muñiz; Carlos Guarner
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  368     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-03     Completed Date:  2013-01-17     Revised Date:  2014-02-27    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  11-21     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00414713
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Adult
Erythrocyte Transfusion / adverse effects,  methods*
Esophageal and Gastric Varices / therapy
Gastrointestinal Hemorrhage / blood,  therapy*
Gastroscopy
Hematemesis / therapy
Hemoglobins / analysis*
Humans
Kaplan-Meier Estimate
Melena / therapy
Chemical
Reg. No./Substance:
0/Hemoglobins
Comments/Corrections
Comment In:
J Hepatol. 2014 Feb;60(2):453-4   [PMID:  24055549 ]
Praxis (Bern 1994). 2013 May 8;102(10):611-2   [PMID:  23644248 ]
J Fam Pract. 2013 Sep;62(9):E6-8   [PMID:  24080565 ]
Rev Clin Esp. 2013 Jun-Jul;213(5):258   [PMID:  23940852 ]
N Engl J Med. 2013 Jan 3;368(1):75-6   [PMID:  23281980 ]
N Engl J Med. 2013 Apr 4;368(14):1362   [PMID:  23550680 ]
Ann Intern Med. 2013 Mar 19;158(6):JC6   [PMID:  23552808 ]
N Engl J Med. 2013 Apr 4;368(14):1361-2   [PMID:  23550679 ]
N Engl J Med. 2013 Apr 4;368(14):1361   [PMID:  23550678 ]
N Engl J Med. 2013 Apr 4;368(14):1362-3   [PMID:  23550677 ]
Nat Rev Gastroenterol Hepatol. 2013 Feb;10(2):66   [PMID:  23318266 ]
Erratum In:
N Engl J Med. 2013 Jun 13;368(24):2341

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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