Document Detail

Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis.
MedLine Citation:
PMID:  18443023     Owner:  NLM     Status:  MEDLINE    
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.
Charles Natanson; Steven J Kern; Peter Lurie; Steven M Banks; Sidney M Wolfe
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, N.I.H., Extramural     Date:  2008-04-28
Journal Detail:
Title:  JAMA     Volume:  299     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-05-21     Completed Date:  2008-05-28     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2304-12     Citation Subset:  AIM; IM    
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MeSH Terms
Blood Substitutes / adverse effects*
Hemoglobins* / adverse effects
Myocardial Infarction / epidemiology
Raffinose / adverse effects,  analogs & derivatives
Reg. No./Substance:
0/Blood Substitutes; 0/HBOC 201; 0/Hemoglobins; 0/O-raffinose cross-linked human hemoglobin; 0/PolyHeme; N5O3QU595M/Raffinose
Comment In:
ACP J Club. 2008 Nov 18;149(5):4   [PMID:  19014171 ]
JAMA. 2008 Sep 17;300(11):1300   [PMID:  18799441 ]
JAMA. 2008 Sep 17;300(11):1295; author reply 1298-9   [PMID:  18799436 ]
JAMA. 2008 Sep 17;300(11):1296; author reply 1298-9   [PMID:  18799438 ]
JAMA. 2008 Sep 17;300(11):1297-8; author reply 1298-9   [PMID:  18799439 ]
JAMA. 2008 Sep 17;300(11):1297; author reply 1298-9   [PMID:  18799440 ]
JAMA. 2008 May 21;299(19):2324-6   [PMID:  18443022 ]
JAMA. 2008 Sep 17;300(11):1295-6; author reply 1298-9   [PMID:  18799435 ]
JAMA. 2008 Sep 17;300(11):1296-7; author reply 1298-9   [PMID:  18799437 ]
Erratum In:
JAMA. 2008 Sep 17;300(11): 1300

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

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