PolyHeme Study Results Reported
Media Contact: Mary Margaret Colliver, 859-361-1887
Lexington, Ky. (Sept. 10, 2008) - Results of a trauma research study with the blood substitute PolyHeme have been analyzed and are being reported across the nation. This study enrolled patients who were at risk of dying from severe traumatic injuries and blood loss, and was conducted in 19 states at 32 Level I trauma centers, including the University of Kentucky between January 2004 and July 2006.
The study was conducted under a federal regulation that allows research in certain emergency, life-threatening situations using an exception from the requirement for the research subjects to provide informed consent at the time of enrollment. PolyHeme is a treatment fluid manufactured by Northfield Laboratories Inc. in Evanston, Ill. from human blood. In previous studies and in Jehovah's Witnesses it has been shown to be life-sustaining. It is intended for use in bleeding patients for whom blood is not immediately available but is not expected to replace blood transfusions.
Based upon these results, Northfield Laboratories intends to request that the drug be approved, for patients who are bleeding and at risk of dying but for whom no blood is available, by the U.S. Food and Drug Administration.
Before the study began, UK completed a process of community notification and consultation in connection with this study, as is mandated by the federal regulations. This community notification occurred under the direction of trauma surgeon Dr. Andrew Bernard in conjunction with the Institutional Review Board (IRB) at UK, The IRB is an independent body composed of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of patients enrolled in clinical trials. Based on its comprehensive review of the study protocol, results of previous studies of the blood substitute and the response of the community to participation in the study, the IRB gave approval for the study to be conducted at UK. An independent data monitoring committee (IDMC), a group of experts not associated with Northfield, periodically evaluated the safety data during the study and made recommendations relating to the continuation or modification of the study to minimize any identifiable risks to patients.
In this clinical study, injured adults meeting the eligibility criteria were randomly assigned to initially receive either PolyHeme or the current standard of care (salt water) in order to compare survival. Patients who had severe injuries and blood loss were enrolled at the scene of injury. Patients who were pregnant, who had serious head injuries, required cardiopulmonary resuscitation (CPR), or who had a known objection to blood transfusion were not included in the study.
Study participation began before arrival at the hospital, either at the scene of the injury or in the ambulance or helicopter, and continued in the early part of hospitalization. Patients in the PolyHeme group received PolyHeme up to six units or for up to 12 hours after injury whichever occurred first. Patients who continued to bleed received donated blood thereafter. Patients in the control group received salt water through their veins at the scene and in the ambulance or helicopter and were given donated blood transfusions as needed upon arrival at the hospital.
714 patients were enrolled nationwide, 34 at the University of Kentucky. The average patient was 37 years old and most (79%) were male. Eighty-two patients died, 46 (13 percent) of the 349 patients who received PolyHeme and 36 (10 percent) of the 365 patients who received salt water. The death rates in the PolyHeme group and the salt water group were statistically the same. The need for donated blood transfusion was less in patients treated with PolyHeme. Serious adverse events occurred with the same frequency in either group.
PolyHeme was studied for use in bleeding patients without early access to blood, not for use in place of blood when blood is available. Based on the results of this study, Northfield Laboratories plans to proceed with a biologic license application (BLA), seeking approval for use of PolyHeme in bleeding patients who do not have access to blood.
According to the Centers for Disease Control, trauma is the leading cause of death in Americans under the age of 45, claiming more than 140,000 lives and permanently disabling 80,000 people each year. Forty seven million Americans live more than an hour away from a trauma center and only one in four live in an area served by a coordinated trauma care system. Sixty percent of trauma deaths occur in rural settings, even though those areas account for only 20 percent of the U.S. population and one third of all trauma deaths occur prior to arriving at a trauma center.
For more information, contact the PolyHeme Hotline at 859-323-6346 ext 276 or by e-mail.