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.
Back
to Top
|
