Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial

Ernest E. Moore; Frederick A. Moore; Timothy 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; Mary C. McCarthy

doi:10.1016/j.jamcollsurg.2008.09.023

Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial

Ernest E. Moore, Frederick A. Moore, Timothy 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, Mary C. McCarthy

Wright State University

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Abstract

<p> <h4 id="x-x-absSec_1"> Background </h4> <p id="x-x-simple-para0080"> 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. <h4 id="x-x-absSec_2"> Study Design </h4> <p id="x-x-simple-para0085"> 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. <h4 id="x-x-absSec_3"> Results </h4> <p id="x-x-simple-para0090"> 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. <h4 id="x-x-absSec_4"> Conclusions </h4> <p id="x-x-simple-para0095"> 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. </p> </p> </p> </p></p>

Original language	American English
Journal	Journal of the American College of Surgeons
Volume	208
DOIs	https://doi.org/10.1016/j.jamcollsurg.2008.09.023
State	Published - Jan 1 2009

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Medical Specialties
Medicine and Health Sciences
Surgery

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Moore, E. E., Moore, F. A., Fabian, T., Bernard, A. C., Fulda, G. J., Hoyt, D. B., Duane, T. M., Weireter, L. J., Gomez, G. A., Cipolle, M. D., Rodman, G. H., Malangoni, M. A., Hides, G. A., Omert, L. A., Gould, S. A., & McCarthy, M. C. (2009). Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial. Journal of the American College of Surgeons, 208. https://doi.org/10.1016/j.jamcollsurg.2008.09.023

Moore, EE, Moore, FA, Fabian, T, Bernard, AC, Fulda, GJ, Hoyt, DB, Duane, TM, Weireter, LJ, Gomez, GA, Cipolle, MD, Rodman, GH, Malangoni, MA, Hides, GA, Omert, LA, Gould, SA & McCarthy, MC 2009, 'Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial', Journal of the American College of Surgeons, vol. 208. https://doi.org/10.1016/j.jamcollsurg.2008.09.023

@article{1adae3ae12914bdb99728b191576162d,

title = "Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial",

abstract = " 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. ",

author = "Moore, {Ernest E.} and Moore, {Frederick A.} and Timothy Fabian and Bernard, {Andrew C.} and Fulda, {Gerard J.} and Hoyt, {David B.} and Duane, {Therese M.} and Weireter, {Leonard J.} and Gomez, {Gerardo A.} and Cipolle, {Mark D.} and Rodman, {George H.} and Malangoni, {Mark A.} and Hides, {George A.} and Omert, {Laurel A.} and Gould, {Steven A.} and McCarthy, {Mary C.}",

year = "2009",

month = jan,

day = "1",

doi = "10.1016/j.jamcollsurg.2008.09.023",

language = "American English",

volume = "208",

journal = "Journal of the American College of Surgeons",

}

TY - JOUR

T1 - Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial

AU - Moore, Ernest E.

AU - Moore, Frederick A.

AU - Fabian, Timothy

AU - Bernard, Andrew C.

AU - Fulda, Gerard J.

AU - Hoyt, David B.

AU - Duane, Therese M.

AU - Weireter, Leonard J.

AU - Gomez, Gerardo A.

AU - Cipolle, Mark D.

AU - Rodman, George H.

AU - Malangoni, Mark A.

AU - Hides, George A.

AU - Omert, Laurel A.

AU - Gould, Steven A.

AU - McCarthy, Mary C.

PY - 2009/1/1

Y1 - 2009/1/1

N2 - 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.

AB - 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.

UR - https://corescholar.libraries.wright.edu/surg/600

U2 - 10.1016/j.jamcollsurg.2008.09.023

DO - 10.1016/j.jamcollsurg.2008.09.023

M3 - Article

VL - 208

JO - Journal of the American College of Surgeons

JF - Journal of the American College of Surgeons

ER -

Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial

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