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Print, E-mail or Add to myLoyola bookmarksYou are here: Home > Features > PolyHeme® Blood Substitute Trauma 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:
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Loyola news release
PolyHeme® study survey
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Regulatory Exception for Studies Conducted in Emergency Settings
Complete Regulation for the Protection of Human Research Subjects (Section 50.24)

 

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