PolyHeme Trial to Begin Monday at Duke University Hospital

DURHAM, N.C. – After a series of delays, a clinical trial designed to test an oxygen-carrying blood substitute in trauma victims being transported to Duke University Hospital (DUH) will begin on July 18, 2005. Only trauma patients being transported to DUH by Durham Emergency Medical Services (EMS) ambulances would potentially be enrolled in the study, providing they meet specific eligibility requirements.

The clinical trial will test the safety and effectiveness of the blood substitute called PolyHeme in comparison to standard care in people who are critically injured and bleeding due to traumatic injuries from such incidents as shootings, motor vehicle crashes or construction-site accidents.

For eligible trauma victims, participation in the clinical trial will begin before their arrival at the Duke emergency department, either at the scene of injury or in an ambulance. Along with standard supportive care, they will receive either PolyHeme or a saline (salt water) solution. PolyHeme may be administered for up to 12 hours post-injury while the person is hospitalized. Those initially given saline solution on the way to the hospital will receive blood rather than PolyHeme, if needed, once they reach Duke. The study will be conducted by personnel in Duke Hospital's Trauma Center, with help from Durham County EMS. The EMS group completed training for the PolyHeme trial earlier this month.

Researchers will compare the survival rates of people who receive the blood substitute to those receiving the usual treatment with saline solution. Due to the extent and nature of their injuries, most people who are eligible for this study will be unable to provide informed consent for participation in the trial. For those unable to give informed consent, 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.

Federal regulations require "waiver of consent" study investigators to hold public meetings to educate the community in which the trial is to be conducted; answer questions from the community about the study; and obtain feedback from citizens regarding the proposed clinical trial. Public meetings to discuss the PolyHeme study were held in Durham over several weeks last summer. According to the investigators, the proposed study met with majority approval by citizens who attended the meetings.

People who do not wish to participate in this clinical trial -- should they experience traumatic injuries -- can opt out of the study by obtaining an "opt out" bracelet from Duke. To opt out, they should send a letter to Dr. Steven Vaslef, DUMC Box 2601, Duke University Medical Center, Durham, NC, 27710, or contact Angela King at 919-668-8686, or via email at: Please specify "PolyHeme" or "Opt Out" in the subject line.

"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 if PolyHeme proves to be effective, having the ability to use it to provide treatment with an oxygen-carrying solution means we'll be better able to keep their hemoglobin levels up and increase their likelihood for survival."

Approval for the clinical trial was given by the Duke Institutional Review Board (IRB) late last year. The Duke IRB is the executive body responsible for ensuring that clinical trials at Duke University Medical Center are conducted with the highest ethical standards and most rigorous scientific criteria. The Durham County Board of Commissioners voted on Nov. 8, 2004 to approve the contractual agreement between Duke University Hospital and Durham County Emergency Medical Services (EMS). The North Carolina Medical Board has also approved the study. Earlier this year, Duke was one of five North Carolina-based medical centers to petition for a state rules change regarding waiver of consent clinical trials. Both the NC Medical Care Commission and the NC Review Commission approved a rule change that permits waiver of consent in emergency situations. The new rule went into effect on April 1, 2005.

To be considered eligible for this study, a trauma victim must be at least 18 years old, critically injured, losing a large amount of blood and in shock. Only patients who are to be transported to Duke by Durham County EMS ground ambulances will be considered for this study, as air transport medical teams have access to and can provide blood transfusions en route to the trauma center.

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, and it creates less risk of disease transmission, and has a shelf-life of 12 months as opposed to the 42-day shelf life of whole blood, the researchers said.

"We're hopeful that the blood substitute will be effective," Vaslef added. "It may be better and safer than human blood, because it's universally compatible across all blood types. But that remains to be proven."

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. Northfield Laboratories Inc., of Evanston, Ill., manufacturer of PolyHeme, is funding the study. PolyHeme is a universally compatible, oxygen-carrying resuscitative fluid designed for use in urgent blood-loss situations where blood is not immediately available. Vaslef holds no financial interest in Northfield Laboratories, Inc.