ALBANY, N.Y., September 7, 2005 – The Albany Medical Center is one of a select number of Level 1 trauma centers in the U.S. chosen to participate in a groundbreaking national clinical trial to evaluate the safety and efficacy of PolyHeme—a temporary oxygen-carrying red blood cell substitute— and its ability to increase survival of trauma patients.
“We are excited to be included in this groundbreaking clinical trial,” said Carl Rosati, M.D., director, section of trauma, division of general surgery, and principal investigator of the study. “Trauma-related injuries are a leading cause of death among Americans under 45 years of age. In fact, almost one in five trauma patients die from their injuries. If we can begin to administer an oxygen-carrying solution very early and keep these patients’ hemoglobin levels up, we may see more survivors.”
PolyHeme is a universally compatible, oxygen-carrying resuscitative fluid derived from human blood and is designed for use in cases of major blood loss such as shootings, motor vehicle or construction-site accidents when blood is urgently needed but is not immediately available.
Under the study protocol, PolyHeme would be administered before arrival at the hospital, either at the scene of the injury or in the ambulance, and would continue during a 12-hour post-injury period in the hospital. Because of its fragility, ambulances are unable to carry blood, so researchers are looking for a product that can be used at the scene of an accident to save lives. 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, followed in the hospital by donated blood, if needed.
To be considered eligible for this study, patients must be at least 18-years old, critically injured, and in an emergency situation where they are losing a large amount of blood and are in a state of shock. Patients with severe brain injuries or irreparable injuries, those who are known to object to blood transfusions due to religious reasons and women who are obviously pregnant will be excluded from the study. Only patients who are transported to Albany Med by LifeNet “MedFlight” helicopter or by ground ambulance by participating emergency medical services agencies within Albany, Saratoga, Schenectady and Rensselaer counties will be considered for this study.
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).
The Institutional Review Board (IRB) at Albany Medical Center requires the study investigators to hold public meetings to educate the public and answer their questions about the study in lieu of informed consent. Albany Med’s participation in this study is contingent upon the IRB’s approval.
A series of public meetings at which citizens can ask additional questions or obtain a bracelet allowing them to opt out of the study will take place at 7 p.m. Wednesday, September 14 and at 7 p.m. Wednesday, October 5 at the Huyck Auditorium at Albany Medical Center. In addition, a representative will be at the Empire State Plaza concourse level on September 15, 20, 21, 26 and 27. For additional information, individuals can call (518) 262-2828.
“Our top priority is the safety of our patients, so we want to hear any concerns that the public might have,” said Rosati. “It’s important that people ask questions and voice their opinions before the study begins. That way, we can help them understand the importance of this study and how it could positively impact trauma care or issue them a bracelet to wear during the duration of the study that allows them to opt out in the event that they are confronted with a medical emergency and need a blood substitute.”
Research published in 2002 in the Journal of the American College of Surgeons showed that 171 patients who received PolyHeme during trauma or urgent surgery had a 30-day death rate of 25 percent, compared with 65 percent in a control group.
The PolyHeme study is a multi-center trial currently underway at 16 trauma centers in the U.S., including the Mayo Clinic in Rochester, MN and the University of California at San Diego Medical Center. Approximately 20 hospitals will eventually participate in the study, which is expected to enroll 720 patients. Northfield Laboratories, Inc., of Evanston, Ill., manufacturer of PolyHeme, is funding the study.
The Albany Medical Center is northeastern New York’s only academic health sciences center. It consists of one of the nation’s oldest medical schools, Albany Medical College; one of New York’s largest teaching hospitals, Albany Medical Center Hospital; and one of the Capital Region’s most active fundraising organizations, the Albany Medical Center Foundation, Inc.