Norfolk, Va. (April 22, 2004) – Representatives from Eastern Virginia Medical School, Sentara Norfolk General Hospital, and the City of Norfolk announced today they are taking part in the first national effort to evaluate the life-saving potential of an experimental blood substitute administered before a patient arrives at the hospital.
The clinical trial will compare the survival rate of severely injured and bleeding patients who receive the blood substitute "PolyHeme" to that of patients who receive the current standard of care, saline solution. PolyHeme is compatible with all blood types and, unlike saline, can transport life-sustaining oxygen throughout the body. Ambulances don’t carry blood because of preservation and typing difficulties.
"We are excited to be a part of this groundbreaking study," said principal investigator Leonard Weireter, M.D., professor of surgery at Eastern Virginia Medical School and director of the Shock Trauma Center at Sentara Norfolk General Hospital. "Trauma-related injuries are a leading cause of death among Americans under age 45, killing one in five trauma patients."
The City of Norfolk agreed to participate in the trial because of the prospect of saving lives, according to Loy Senter, chief of Norfolk Emergency Medical Services. "If we can treat these patients very early with this oxygen-carrying solution, we may be able to improve their odds of surviving," he said.
Because patients eligible for the study are unlikely to be able to provide their consent prior to treatment with PolyHeme, the study is being conducted under federal regulations that permit an exemption from the informed consent requirement. The study will be conducted only in adults and only within the boundaries of the City of Norfolk, according to co-investigator Jon "Jack" Mason, M.D., an operational medical director for Norfolk Fire and Rescue. Mason also is an EVMS associate professor of emergency medicine and assistant medical director of the Emergency Department at Sentara Norfolk General Hospital.
The Institutional Review Board (IRB) of EVMS has approved the first phase of the trial, a "community consultation and public disclosure" period. During this six-week period, investigators will be available to discuss potential risks and benefits from participating in the trial, as well as listen to concerns from all interested groups and individuals. Once the public disclosure period ends, the IRB will meet again to decide if patient enrollment can proceed. The IRB is composed of medical and lay representatives and is responsible for reviewing all research involving humans.
PolyHeme has been studied previously in trauma trials in a hospital setting. PolyHeme is manufactured by Northfield Laboratories, Inc., of Evanston, Illinois.