• Ernest E Moore, Frederick A Moore, Timothy C Fabian, Andrew C Bernard, Gerard J Fulda, David B Hoyt, Therese M Duane, Leonard J Weireter, Gerardo A Gomez, Mark D Cipolle, George H Rodman, Mark A Malangoni, George A Hides, Laurel A Omert, Steven A Gould, and PolyHeme Study Group.
• Department of Surgery, Denver Health Medical Center, University of Colorado, Denver, CO, usa.
• J. Am. Coll. Surg. 2009 Jan 1;208(1):1-13.

BackgroundHuman polymerized hemoglobin (PolyHeme, Northfield Laboratories) is a universally compatible oxygen carrier developed to treat life-threatening anemia. This multicenter phase III trial was the first US study to assess survival of patients resuscitated with a hemoglobin-based oxygen carrier starting at the scene of injury.Study DesignInjured patients with a systolic blood pressureResultsSeven hundred fourteen patients were enrolled at 29 urban Level I trauma centers (79% men; mean age 37.1 years). Injury mechanism was blunt trauma in 48%, and median transport time was 26 minutes. There was no significant difference between day 30 mortality in the as-randomized (13.4% PolyHeme versus 9.6% control) or per-protocol (11.1% PolyHeme versus 9.3% control) cohorts. Allogeneic blood use was lower in the PolyHeme group (68% versus 50% in the first 12 hours). The incidence of multiple organ failure was similar (7.4% PolyHeme versus 5.5% control). Adverse events (93% versus 88%; p=0.04) and serious adverse events (40% versus 35%; p=0.12), as anticipated, were frequent in the PolyHeme and control groups, respectively. Although myocardial infarction was reported by the investigators more frequently in the PolyHeme group (3% PolyHeme versus 1% control), a blinded committee of experts reviewed records of all enrolled patients and found no discernable difference between groups.ConclusionsPatients resuscitated with PolyHeme, without stored blood for up to 6 U in 12 hours postinjury, had outcomes comparable with those for the standard of care. Although there were more adverse events in the PolyHeme group, the benefit-to-risk ratio of PolyHeme is favorable when blood is needed but not available.

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