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JAMA. 2008 May 21;299(19):2304-12. doi: 10.1001/jama.299.19.jrv80007. Epub 2008 Apr 28.

Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis.

Author information

  • 1Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, Maryland 20892, USA. cnatanson@cc.nih.gov

Erratum in

  • JAMA. 2008 Sep 17;300(11): 1300.

Abstract

CONTEXT:

Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.

OBJECTIVE:

To assess the safety of HBBSs in surgical, stroke, and trauma patients.

DATA SOURCES:

PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.

STUDY SELECTION:

Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.

DATA EXTRACTION:

Data on death and myocardial infarction (MI) as outcome variables.

RESULTS:

Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P > or = .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.

CONCLUSION:

Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI.

Comment in

PMID:
18443023
[PubMed - indexed for MEDLINE]
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