Office Of Public Affairs
Utah Study Group Reports Results of Blood Substitute Trauma Study
Three Utah patients participated in the study, but none received the blood substitute known as PolyHeme.
Jul 28, 2008 3:00 PM
Salt Lake City—University of Utah Hospital, LDS Hospital and participating EMS Agencies today reported results of a trauma research study with the blood substitute PolyHeme. The nationwide study enrolled patients who were at risk of dying from severe trauma and blood loss, and was conducted at 32 Level I trauma centers in 19 states. In Utah, three patients participated in the study, but none received the blood substitute.
The study was conducted under a federal regulation that allows research in certain emergent, life-threatening situations using an exception from the requirement for informed consent. The study was reviewed, approved, and conducted under the supervision of the Institutional Review Boards at University of Utah, LDS Hospital and the Utah Department of Health.
In this clinical study, adult patients meeting the eligibility criteria were randomly assigned to initially receive infusions of either PolyHeme or the current standard of care (these patients were known as “Control”) in order to compare survival. Patients who sustained severe injuries and blood loss were enrolled at the scene of injury. Treatment began before arrival at the hospital, either at the scene of the injury or in the ambulance, and continued in the early post-injury period in the hospital.
A total of 714 trauma patients were treated in the study nationwide. Eighty-two patients died, 46 (13 percent) of the 349 patients who received PolyHeme and 36 (10 percent) of the 365 patients who received Control. The difference in deaths between the groups fell outside the boundary to meet the primary efficacy endpoint agreed upon with FDA. However, the difference in the number of deaths was not statistically significant, meaning the outcomes were similar, regardless of the treatment the patient received. Of the 714 patients, 124 had “protocol violations,” meaning they should not have been enrolled, or did not receive the assigned treatment. Of the 590 patients with whom the protocol was correctly followed, 60 patients died, 31 in the PolyHeme group (11%) and 29 (9%) in the control group. In Utah, three patients were enrolled in the study and none died. None of the Utah patients received PolyHeme.
PolyHeme was studied for use in bleeding patients without early access to blood, not for use in place of blood when blood is available. This study was conducted in largely urban areas, where transit times were short. There are many aspects to the evaluation of a potential new therapy before approving it for general use, including what the benefit-to-risk profile of the product is. The patients who would qualify to be given the blood substitute would be at risk of dying from blood loss. Without blood, the risk of dying is even greater. At this time, there is no adequate alternative to blood that can be given to bleeding patients when blood is not available. Based on the results of this study as well as earlier published results, PolyHeme may provide a survival benefit to bleeding patients who do not have access to blood.
Study results were recently presented at a meeting of the American College of Surgeons.
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 lives 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.
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