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PolyHeme®
Multicenter Phase III Trial Fact Sheet
| The PolyHeme® Study
was a landmark Phase III clinical trial |
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- This was 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 was conducted at 30 Level I trauma centers
throughout the U.S.
- 720 patients were enrolled in the trial.
- The primary endpoint of the trial was survival
at 30 days.
- Eligible patients were randomized at the scene
to receive either the standard of care or PolyHeme®.
- Because the patients eligible for the study were
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).
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