Lillian S. Kao, MD; Alexander Gallus, MD
Do hemoglobin-based blood substitutes (HBBSs) increase risk for myocardial infarction (MI) and death more than usual care in surgical, trauma, and stroke settings?
Studies selected evaluated HBBSs in patients > 18 years of age and reported outcomes for death or MI. Studies of healthy volunteers were excluded.
PubMed, EMBASE/Excerpta Medica, and Cochrane Library (1980 to Mar 2008), and US Food and Drug Administration (FDA) advisory committee meeting materials were searched for English-language, randomized controlled trials (RCTs). Internet searches for unpublished data reported in press releases from companies developing HBBSs were conducted. 15 RCTs (2 with data available only from press releases) and a pooled analysis presented by the FDA met the selection criteria (n = 3711). 9 RCTs evaluated HemAssist (Baxter Healthcare Corp., Deerfield, Illinois, USA), 3 used PolyHeme (Northfield Laboratories Inc., Evanston, Illinois, USA), 2 used Hemolink (Hemosol BioPharma Inc., Mississauga, Ontario, Canada), 1 used Hemospan (Sangart Inc., San Diego, California, USA), and the FDA analysis evaluated Hemopure (Biopure Corp., Cambridge, Massachusetts, USA). 9 RCTs and the FDA analysis involved patients who had surgery, 5 RCTs involved patients with trauma, and 1 involved patients with stroke. 4 RCTs did not use blinding.
Meta-analysis showed that HBBSs increased risk for mortality and MI more than usual care in patients who had surgery, trauma, or stroke (Table).
In patients who have had surgery, trauma, or stroke, hemoglobin-based blood substitutes as a class increase risk for mortality and myocardial infarction more than usual care.
Hemoglobin-based blood substitutes (HBBSs) vs usual care in surgical, trauma, and stroke settings*
*Abbreviations defined in Glossary. RRI, NNH, and CI calculated from data in article using a fixed-effects model.
†Estimated without adjustment for length of follow-up.
Kao LS, Gallus A. Review: Hemoglobin-based blood substitutes increase mortality and myocardial infarction in surgical, trauma, and stroke settings. Ann Intern Med. ;149:JC5–4. doi: 10.7326/0003-4819-149-10-200811180-02004
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Published: Ann Intern Med. 2008;149(10):JC5-4.
Emergency Medicine, Neurology, Stroke.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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