The University Hospital Chosen to Study Investigational Blood Substitute in Trauma Patients
Contact: Patty Holiday (513) 585-7200
Date: 01/05/2004
Cincinnati residents may be involved in a groundbreaking national clinical trial to evaluate the safety and efficacy of PolyHemeŽ, an oxygen-carrying blood substitute, in increasing survival of critically injured and bleeding patients. The University Hospital is one of a select number of Level I trauma centers chosen to participate in the trial and will be working with Cincinnati Fire Department and EMS personnel.
Under the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the ambulance, and continue during a 12-hour post injury period in the hospital. Since blood is not presently carried in ambulances, the use of PolyHeme in these settings has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is currently not available. The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution. Only persons in Cincinnati over 18 years of age who meet specific study criteria will be eligible for inclusion.
Because the patients eligible for this study are unlikely to be able to provide prospective informed consent due to the extent and nature of their injuries, the study will be conducted under federal regulations that allow for clinical research in emergency settings using an exception from the requirement for informed consent (21 CFR 50.24). Use of this provision in a study protocol is granted by the Institutional Review Board (IRB).
The community is invited to attend information sessions at which University Hospital staff will explain these regulations and the potential risks and benefits associated with participation in this study. Concerns will be solicited and addressed. Below is the schedule of sessions.
Jan. 13 Millvale Community Council 4 p.m.
Jan. 15 East Westwood Community Council 7 p.m.
Jan. 20 Avondale Community Council 6:30 p.m.
Jan. 21 Cincinnati City Council 11 a.m.
Jan. 22 Leblonde Community Center 1 p.m.
Feb. 9 Northside Community Council 8 p.m.
Feb. 10 Downtown Community Council 6:30 p.m.
"We are excited to be included in this groundbreaking clinical trial," said Donald Locasto, M.D., principal investigator of the study and emergency medicine physician. "Trauma-related injuries are a leading cause of death among Americans under 45 years old, according to the CDC's National Center for Injury Prevention and Control. In fact, almost one in five trauma patients die from their injuries. If we can begin to treat these patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we might well see more survivors," he added.
PolyHemeŽ is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available. It has been studied extensively in trauma trials in the hospital setting. The IRB has approved this clinical trial to be performed without the informed patient consent because patients will be in a life-threatening situation requiring emergency medical intervention; treatments currently available are unsatisfactory; potential risks are reasonable; participation in the study can provide a direct benefit to the patients enrolled, in the form of increased survival; and the research cannot be practicably conducted without an exception from informed consent requirements. PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Ill.
The University Hospital is part of the Health Alliance, an integrated health care delivery system that also includes The Christ Hospital, The St. Luke Hospitals, The Jewish Hospital, The Fort Hamilton Hospital and the physicians of Alliance Primary Care. To view other Health Alliance news releases, go to www.health-alliance.com/pressroom.
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