Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial.
Moore, Ernest E. MD, FACS a,*; Moore, Frederick A. MD, FACS b; Fabian, Timothy C. MD, FACS c; Bernard, Andrew C. MD, FACS d; Fulda, Gerard J. MD, FACS e; Hoyt, David B. MD, FACS f; Duane, Therese M. MD, FACS g; Weireter, Leonard J. Jr MD, FACS h; Gomez, Gerardo A. MD, FACS i; Cipolle, Mark D. MD, FACS j; Rodman, George H. Jr MD, FACS k; Malangoni, Mark A. MD, FACS l; Hides, George A. BA m; Omert, Laurel A. MD n; Gould, Steven A. MD, FACS n,o; PolyHeme Study Group
[Article] Journal of the American College of Surgeons. 208(1):1-13, January 2009.

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BACKGROUND: Human 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 DESIGN: Injured patients with a systolic blood pressure <= 90 mmHg were randomized to receive field resuscitation with PolyHeme or crystalloid. Study patients continued to receive up to 6 U of PolyHeme during the first 12 hours postinjury before receiving blood. Control patients received blood on arrival in the trauma center. This trial was conducted as a dual superiority/noninferiority primary end point.

RESULTS: Seven 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.

CONCLUSIONS: Patients 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.

(C) 2009 by Lippincott Williams & Wilkins, Inc.