Dec.16, 2005 — After listening to public comment for five months, Utah’s two major trauma centers for adult patients, University of Utah Hospital and LDS Hospital, are ready to enroll patients in a groundbreaking national clinical trial to test a new synthetic blood product in the treatment of trauma patients. The hospitals will hold a media briefing on Dec. 20 at the West Valley City Fire Department.
The Utah hospitals are among 20 major U.S. trauma centers expected to participate in the one-year study, evaluating the safety and efficacy of PolyHeme®, a hemoglobin-based, oxygen-carrying blood substitute, to increase survival of critically injured and bleeding patients.
The University of Utah and LDS hospitals, under the auspices of their Institutional Review Boards (IRB), have conducted a process of community notification and consultation in connection with this study, as is mandated by federal regulation. As a result of this process, and because the response of the community to participating in this study was generally positive, the IRB authorized the training of Emergency Medical Services personnel and hospital staff who will be conducting the study.
University Health Care’s AirMed, Intermountain Healthcare’s Life Flight, and first-responder crews from four area municipalities (Salt Lake City, West Valley City, Sandy City, and the Park City Fire Department) will use the blood substitute, PolyHeme®, to treat patients in hemorrhagic shock either at the scene of the injury or in the ambulance, and continue during a 12-hour post-injury period in the hospital.
“Patient enrollment may now begin,” said Stephen E. Morris, M.D., University Hospital trauma director and principal investigator for the trial.
A solution of chemically modified human hemoglobin that can be rapidly and massively infused, PolyHeme®, has a number of advantages for use in the field, according to Morris. “It’s immediately available and is compatible with all blood types,” Morris said. “If we can treat trauma patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we could see more survivors.”
“This is a very important study, which could lead to a major change in the way that critically injured and bleeding patients are initially treated, which could potentially lead to improved outcomes in these patients,” said Todd Allen, M.D., LDS Hospital co-director of trauma research.
The yearlong study will compare the survival rate of patients receiving PolyHeme® to that of patients receiving the current standard care, which is allogenic blood or red blood cells and saline solution. Thirty-six patients may be enrolled in the Utah portion of the trial; 720 will participate nationwide. Half of them will receive the blood substitute (assigned randomly) and half will receive traditional therapy.
The clinical trial is being conducted under an informed-consent wavier from the U.S. Food and Drug Administration, which allows for clinical research in emergency settings where patients cannot give permission for treatment, such as a motor vehicle accident.
Persons wishing to decline participation in this study may contact study coordinator, Lisa Reynolds, R.N., 801-585-0385, to obtain a wristband expressing this choice. PolyHeme® has previously been studied in trauma patients in the hospital setting.
PolyHeme® is manufactured by Northfield Laboratories Inc., of Evanston, Illinois.
University of Utah Health Sciences Center Office of Public Affairs
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(801) 581-7387 fax: 585-5188
http://uuhsc.utah.edu/pubaffairs/