ALBANY, N.Y., January 6, 2006—The Albany Medical Center announced today that patient enrollment is beginning in a national clinical trial evaluating the safety and efficacy of PolyHeme—an investigational temporary oxygen-carrying red blood cell substitute—and its ability to increase survival of trauma patients.
“Patient enrollment may now begin,” said Carl Rosati, M.D. director, section of trauma, division of general surgery, and the study’s principal investigator. “This is a very important study that could lead to a major change in the way critically injured and bleeding patients are initially treated, and potentially lead to improved patient outcomes.”
Under the study protocol, administration of PolyHeme will 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 this is a controlled clinical study, patients will receive infusions of either PolyHeme or the current standard treatment, which is a saline solution followed in the hospital by donated blood, when needed.
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).
Albany Med, under the auspices of its Institutional Review Board (IRB), recently undertook 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 training of emergency medical services (EMS) personnel and hospital staff who will be conducting this study.
The treatment under investigation, PolyHeme, is a temporary oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available. Because it is universally compatible with all blood types, it is immediately available and has an extended shelf life of over 12 months. PolyHeme has previously been studied in trauma patients in the hospital setting. PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Illinois.
Persons wishing to decline participation in this study may visit the main information desk at the Albany Medical Center, or may contact the study coordinator, Susan Rauch, at (518) 262-2828 to obtain a wristband expressing this choice.