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Trial
PolyHeme®
Blood Substitute Trauma Trial
Trial
Description: A Phase III, Randomized, Controlled,
Open-Label Multicenter, Parallel Group Study Using Provisions
for Exception from Informed Consent Requirements Designed
to Evaluate the Safety and Efficacy of Poly SFH-P Injection
[Polymerized Human Hemoglobin (Pyridoxylated) PolyHeme®]
When Used to Treat Patients in Hemorrhagic Shock Following
Traumatic Injuries Beginning in the Prehospital Setting
Exception
from Informed Consent under 21 CFR 50.24: This provision
is made when patients are in a life-threatening situation
requiring emergency medical intervention, currently
available treatments are unsatisfactory, participation
in the study could provide a direct benefit to the patients
enrolled in the form of survival, the risks are reasonable,
and the research could not be conducted without an exception
from informed consent regulations. Typically, patients
who are severely injured and bleeding are unable to
grant consent for treatment because of the nature and
extent of their injuries.
Study
Purpose: To evaluate the life-saving potential of
PolyHeme® when given to severely injured
and bleeding patients, starting at the scene of injury.
Principal
Investigator: Richard
L. Gamelli, M.D., professor of trauma surgery, Loyola
University Stritch School of Medicine, chair, Department
of Surgery, Loyola University Health System
Co-Investigator:
Dr.
Mark Cichon, associate professor of surgery, Loyola
University Chicago Stritch School of Medicine; director,
Emergency Medical Services, Loyola University Health
System
Contact
Information: (708) 327-2452, bloodsubstitute@lumc.edu
Sponsor:
Northfield Laboratories Inc., Evanston, Ill.
Related
links:
Community
meetings
Frequently
asked questions
Loyola
news release
PolyHeme®
study survey
Feedback
form
Regulatory
Exception for Studies Conducted in Emergency Settings
Complete
Regulation for the Protection of Human Research Subjects
(Section 50.24)
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