Polyheme® Blood Substitute Trauma Study
Study Completed July 31, 2006
Thank you for your interest in this study, which was completed July 31, 2006. For additional information regarding the trial results, refer to http://www.northfieldlabs.com.
Study Title: 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 and 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 the PolyHeme® blood substitute when given to severely injured and bleeding patients, beginning at the scene of injury.
Principal Investigator : Stephen E. Morris, MD , Director of Trauma, University of Utah Health Sciences Center, Co-Director, Intermountain Burn Center, University of Utah Health Sciences Center
Contact Information : Lisa Reynolds, RN, BSN, Clinical Research Coordinator, Department of Surgery, University of Utah School of Medicine, (801) 585-0385, lisa.reynolds@hsc.utah.edu
Sponsor : Northfield Laboratories Inc., Evanston , Ill.
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