University, LDS Hospitals Seek Public Comment on Trial of New Blood Substitute for Trauma Patients

University, LDS Hospitals Seek Public Comment on Trial of New Blood Substitute for Trauma Patients

Jun 13, 2005 6:00 PM

SALT LAKE CITY - Utahs two major trauma centers for adult patients, University of Utah Hospital and LDS Hospital, have begun a period of public comment on their anticipated participation in a national clinical trial to test a new synthetic blood product in the treatment of trauma patients.

The Utah facilities are among 20 major trauma centers across the nation expected to participate in the one-year study, which will evaluate the safety and efficacy of PolyHeme?, a hemoglobin-based, oxygen-carrying blood substitute, to increase survival of critically injured and bleeding patients.

The clinical trial is being conducted under an informed consent waiver from the U.S. Food and Drug Administration (FDA) that allows for clinical research in emergency settings where it is impossible for a patient to give permission for treatment, such as in the aftermath of a motor vehicle accident.

Both the FDA and the Institutional Review Boards (IRBs) of both hospitals (responsible for initial and continuing review and approval of the study) require that broad public notification about the trial be made, giving the public an opportunity to voice any concerns.

The notification process includes community meetings, newspaper notices, and the opportunity for individuals to comment online via an informational Web site. For those who do not wish to be a part of the trial, the hospitals will make available plastic bracelets indicating that the wearer declines participation in the study.

If their IRBs approve the hospitals participation in the trial, AirMed, Life Flight and first-responder crews from four area municipalities (Salt Lake County and Salt Lake, West Valley and Sandy cities) will begin using the blood substitute, PolyHeme?, to treat patients in hemorrhagic shock at the scene of the injury, continuing for up to 12 hours after arrival at the hospital.

A solution of chemically modified human hemoglobin which can be rapidly and massively infused, PolyHeme? has a number of advantages for use in the field, according to Stephen E. Morris, M.D., trauma director at University of Utah Hospital and principal investigator for the trial.

Its immediately available and is compatible with all blood types, said Morris. If we can treat trauma patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we could see more survivors.

Current mortality statistics are sobering. Trauma-related injuries are a leading cause of death among Americans under 45 years old, according to the Centers for Disease Control and Prevention and the National Center for Injury Prevention and Control. Nearly one in five severe trauma patients dies from injuries.

The manufacturers of PolyHeme?, Northfield Laboratories, Inc., Evanston, Illinois, report it has been safe and well tolerated in in-hospital trials.

The proposed year-long study will compare the survival rate of patients receiving PolyHeme? to that of patients who receive the current standard of 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.

University Hospital has scheduled two community meetings to elicit public comment on the trial and answer any questions about it:

June 21 (Tues.), 4:30-6 p.m., Sandy Library, 10100 South 1300 East

June 29 (Wed.), 6:30-8 p.m., West Valley Family Fitness Center, 5415 West 3100 South

A third meeting in Salt Lake City will be announced.

For more information about the clinical trial and to voice an opinion on the study, visit the Web site: uuhsc.utah.edu/polyheme or contact Lisa Reynolds, R.N.: 801-585-0385.

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For further information contact:

Stephen Morris, M.D. Trauma Director University Hospital 801-581-6255

Lisa Reynolds, R.N. Clinical Research Coordinator University Hospital 801-585-0385 lisa.reynolds@hsc.utah.edu

Sophia Twaddell Vice President, Corporate Communications Northfield Laboratories, Inc. stwaddell@northfieldlabs.com 847-864-3500

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