Researchers and clinicians at Duke University Hospital plan to participate in the nation's first phase three clinical tests of an oxygen-carrying blood substitute in trauma patients before they reach the emergency room.
Beginning this summer, they hope to join researchers at other trauma centers in the U.S. to test the safety and efficacy of the blood substitute called PolyHeme in people who are critically injured and bleeding due to traumatic injuries from such incidents as shootings, motor vehicle crashes or construction-site accidents.
Treatment of the trauma patients with the blood substitute would begin before their arrival at the Duke emergency department, either at the scene of injury or in an ambulance, and continue for twelve hours post-injury while the patient is in the hospital. The study will be conducted by personnel in Duke Hospital's Trauma Center, with help from Durham Emergency Medical Services.
"This is a groundbreaking clinical trial for a much-needed blood substitute and we're very pleased to be involved," said Steven Vaslef, M.D., medical director of the Duke Trauma Center and lead investigator at the Duke study site. "Traumatic injury is a leading cause of death in Americans, but no one expects to be injured. It is vitally important to treat trauma patients as early as possible. The treatment process typically begins at the scene of injury, so having the ability to provide treatment with an oxygen-carrying solution may increase the likelihood for survival."
Most ground transport ambulances do not carry blood on board because of storage, temperature and compatibility concerns. The current standard of care calls for the use of saline solution in situations where blood is not available -- such as at the scene of an accident or in an ambulance -- to compensate for lost blood volume in patients who have sustained significant blood loss. Lost blood volume, and the corresponding drop in blood pressure, can lead to oxygen and nutrient-starvation in vital organs of the body.
Continued lack of tissue perfusion can lead to organ failure and eventually to death, the researchers said. Saline solution can be used in place of human blood to increase volume in the blood stream, but it cannot deliver oxygen in sufficient quantities. The blood substitute PolyHeme is capable of efficient delivery of oxygen to patients with less risk of disease transmission, and has a shelf-life of 12 months as opposed to the 42-day shelf life of whole blood.
Researchers will compare the survival rates of patients who receive the blood substitute to those receiving saline solution. Due to the extent and nature of their injuries, patients who are eligible for this study will not be able to provide informed consent for participation in the trial. Therefore, the study will be conducted under federal regulations that allow for clinical research in emergency settings using an exception (21 CFR 50.24) from the requirement for informed consent.
The Institutional Review Board (IRB) at Duke University Medical Center requires the study investigators to hold public meetings to educate the public and answer their questions about the PolyHeme study in lieu of informed consent, for what is considered to be a "waiver of consent" clinical trial. Duke's participation in the study is contingent upon IRB approval.
"We're hopeful that the blood substitute will be effective," Vaslef added. "It may prove to be better and safer than human blood, because it's universally compatible across all blood types."
Unintentional injuries are the leading cause of death among Americans under 35-years old, according to the National Center for Injury Prevention and Control (NCIPC), part of the Centers for Disease Control and Prevention. Such injuries are the second leading cause of death among Americans aged 35-44. The NCIPC's most recent statistics are based upon data collected in 2001.