Miami Valley Hospital Reports Results of Trauma Study With Blood Substitute Polyheme®
DAYTON, OHIO—April 14, 2008 —Miami Valley Hospital is reporting results of a trauma research study with the blood substitute PolyHeme® that was conducted under a federal regulation (21 CFR 50.24) that allows research in certain emergent, life-threatening situations using an exception from the requirement for informed consent.
This 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.
Prior to the study, Miami Valley Hospital’s Trauma Program, under the direction of the Miami Valley Hospital Institutional Review Board (IRB), completed a process of community notification and consultation, as is mandated by this federal regulation. The IRB is an independent body composed of medical, scientific, and nonscientific members. Their 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, the 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 Miami Valley Hospital. With the completion of the study and presentation of results at the American College of Surgeons meeting on October 10, 2007, Miami Valley Hospital is sharing the results of the study as is required by the regulation.
In this clinical study, adult patients who sustained severe injuries and blood loss, and met the eligibility criteria were enrolled at the scene of injury or enroute to the hospital. Treatment began before arrival at the hospital, and continued in the early post-injury period in the hospital. CareFlight, Miami Valley Hospital’s air ambulance service enrolled those patients included in the study at MVH. Patients who were pregnant, who had serious head injuries, required CPR, or who had a known objection to blood transfusion were not included in the study.
Subjects were randomly assigned to initially receive infusions of either PolyHeme® or the current standard of care (“Control”) in order to compare survival. Patients in the PolyHeme® group received PolyHeme® as their first fluid, to a maximum dose of up to 6 units of PolyHeme® or 12 hours after injury. Patients who continued to bleed received donated blood thereafter. Patients in the Control group received IV salt water at the scene and during transport and were given donated blood transfusions as needed after arrival at the hospital.
There were 714 total trauma patients treated in this study, at all the study sites. Eighty-two patients died, 46 (13%) of the 349 patients who received PolyHeme® and 36 (10%) 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 in the study, 124 had “protocol violations.” Some patients should not have been enrolled, and some did not receive the assigned treatment. Of the 590 patients where the protocol was correctly followed, 60 patients died, 31 in the PolyHeme® group (11%) and 29 (9%) in the control group.
At Miami Valley Hospital 2 patients were treated, and both survived. There was one patient in the PolyHeme® arm, and one patient in the Control arm of the study.
PolyHeme® was studied for use in bleeding patients without early access to blood, not for use in place of blood when blood is available. 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. 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. .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.
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% of the U.S. population.
If desired, more information may be obtained by contacting Northfield Laboratories, study sponsor via phone at (847)864-3500, via e-mail at email@example.com, or by visiting their website at www.northfieldlabs.com. Inquiries may also be directed to Miami Valley Hospital Clinical Research Center at (937) 208-5069.
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