Portland, Ore.

The trauma centers hope to study the safety and effectiveness of PolyHeme, a blood substitute

Trauma researchers at Oregon Health & Science University and Legacy Health System are seeking the community's input on a study that will test an experimental blood substitute called PolyHeme. Members of the public are invited to attend one of several community meetings to learn more about the study (see dates and locations below). Media are invited to learn more about the study and speak with the principal investigators, IRB members and EMS representatives on Monday, March 7 at 10:30 a.m. in the OHSU Child Development and Rehabilitation Center (CDRC) Room 3200.This research project is unique because subjects will be enrolled in the study at the scene of an accident and, due to the life-threatening nature of their injuries, will not be able to consent to receiving the experimental blood substitute. For this reason, the trauma centers are required by federal law to obtain the community's consent before the study can begin.

"Our top priority is the safety of our patients, so we want to hear any concerns that the public might have," said Martin Schreiber, M.D., co-principal investigator and associate professor of surgery in the OHSU School of Medicine. "It's important that people ask questions and voice their opinions now. That way, we can help them understand the importance of this study and how it could positively impact trauma care." Schreiber and Dean Gubler, D.O., M.P.H, assistant medical director of trauma services for Legacy Health System, are co-principal investigators on the study.

According to the U.S. Centers for Disease Control and Prevention, trauma is the leading cause of death for Americans younger than 45. Ambulances cannot carry blood because of its fragility, so researchers are looking for a product that can be used at the scene of an accident to help save lives.

Researchers will study whether PolyHeme is safe and effective at increasing the survival rates of persons with trauma who have suffered massive blood loss. Because PolyHeme can be given to everyone, regardless of blood type, half of the subjects entered into the study will be chosen at random to receive PolyHeme at the scene of the injury or in the ambulance, and throughout the initial 12-hour post-injury period in the hospital. The other half will receive a saline or saltwater solution followed by a blood transfusion at the hospital - the current standard of care.

PolyHeme, manufactured by Northfield Laboratories Inc. of Evanston, Ill., is thought to be beneficial in boosting oxygen levels in the body and reducing the risk for infections and blood waste, but this has not been proved. The risks of PolyHeme include kidney or liver damage, increased blood pressure and allergic reaction. There may be other unforeseen risks.

Nationwide, 16 cities have enrolled subjects in PolyHeme studies. Interim analysis was conducted twice by an independent Data Safety & Monitoring Board after 120 subjects were enrolled, and it was recommended that the trials be continued without modification. More than 700 subjects will be involved in the study across the country and, if approved in Portland, there will be as many as 40 subjects from our community.

Consent Process

Most research in the United States is done with the permission of the research subject through a process called "informed consent." That process involves telling the subject of risks and benefits in order to allow him or her to make an educated decision about whether he or she wants to participate. This study would be conducted under the FDA's regulation that allows research in certain life-threatening situations without obtaining informed consent. The federal regulations that allow this waiver of consent require community consultation to ensure that the public is involved in the decision-making process. Both OHSU and Legacy are holding public meetings and making community announcements to gauge the disposition of Portland-area residents about the ethics of conducting a medical study without prospectively informing the research subject. These meetings will serve as the trauma centers' process for obtaining community consent.

The requested waiver of consent will only affect trauma victims while they are in the field. Informed consent will be sought from relatives at both hospitals' emergency departments. Upon arriving at the hospital, relatives will be given information to help them decide whether they want their family member to continue receiving the experimental blood substitute.

Community Meetings

Public meetings will be held:Monday, March 14 at 7 p.m. at Legacy Emanuel Hospital, Lorenzen Auditorium

Friday, March 18 at 7 p.m. at Legacy Meridian Park Hospital, CHEC Auditorium

Monday, March 28 at 7 p.m. at OHSU, Old Library AuditoriumMembers of the public are encouraged to attend these sessions to ask questions or share their opinion about this research study. In addition, they can visit www.ohsu.edu/polyheme to e-mail the study coordinators or call representatives from the Human Subjects committees at 503 494-7887 (OHSU) or 503 413-2474 (Legacy).

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