PolyHeme® Pivotal Phase III Trial Fact Sheet
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PolyHeme® Pivotal Phase III Trial Fact Sheet

The PolyHeme® Study is a landmark Phase III clinical trial

  • This is the first U.S. trial of a hemoglobin-based oxygen-carrying resuscitative fluid in which treatment begins in the prehospital setting and continues during transport and in the early hospital period.
  • The trial will be conducted in approximately 25-30 Level I trauma centers throughout the U.S.
  • 720 patients will be enrolled in the trial.
  • The primary endpoint of the trial is survival at 30 days.
  • Eligible patients will be randomized at the scene to receive either the standard of care or PolyHeme®.
  • Because the patients eligible for the study are unlikely to be able to provide consent due to the extent and nature of their injuries, the trial will be conducted under federal regulations that allow clinical research in emergency settings using an exception from the requirement for informed consent (21 CFR 50.24).

PolyHeme® has been rapidly infused in trauma patients during urgent life-threatening blood loss in sufficiently large quantities to be considered well-tolerated in this patient population.

  • PolyHeme® replaces both lost blood volume and hemoglobin which are associated with traumatic injury.
  • Patients in the hospital trauma trial received up to 20 units (pints), replacing double the average adult’s blood volume.

PolyHeme’s characteristics may make it useful in both civilian and military settings.

  • Universally compatible
  • Immediately available
  • Has not caused transfusion reactions
  • Has extended shelf life in excess of 12 months
  • Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.

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