Jan. 6, 2005 Hershey, Pa. -- Penn State Milton S. Hershey Medical Center was one of a few Level I trauma centers in the U.S. chosen to participate in a national clinical research study to evaluate the safety and efficacy of PolyHeme, an oxygen-carrying blood substitute, in treating critically injured and bleeding patients.
Under the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the emergency response unit, and continue during a 12-hour post injury period in the hospital. Since blood is not presently carried in ambulances or helicopters, the use of PolyHeme in these settings could address an unmet medical need for an oxygen-carrying solution where blood is not available. The study will compare the survival rate of patients receiving PolyHeme in the ambulance or helicopter, to that of patients who receive the current standard of care, which is saline solution.
"We are excited to be asked to participate in this groundbreaking clinical trial," said Robert Cherry, medical director of the Penn State Hershey Medical Center Trauma Program, assistant professor of surgery in the Penn State College of Medicine, and study principal investigator. "The CDC reports that trauma-related injuries are a leading cause of death among Americans under age 45. The study will investigate whether treating trauma patients very early with an oxygen-carrying solution and keeping their hemoglobin levels up will improve survival."
Because the patients eligible for this study are unable to provide informed consent before receiving PolyHeme due to the extent and nature of their injuries, the study will be conducted under federal regulations that allow for clinical research in emergency settings using an exception from the requirement for informed consent (21 CFR 50.24).
Use of this provision in a study protocol is granted by the institutional review board (IRB) responsible for the initial and continuing review and approval of the research study. Such a decision is based on the finding and documentation that, amongst other things, patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unproven or unsatisfactory, obtaining informed consent is not feasible, potential risks are reasonable in relation to what is known of the condition, participation in the study could provide a direct benefit to the patients enrolled, and the research could not be practicably conducted without an exception from informed consent requirements.
The IRB requires that the medical center team present study information at public meetings and in other forums, and collect public comment about the study. Study investigators will present information at January county commissioners' meetings in the following counties: Dauphin, Perry, Cumberland, Lebanon, Lancaster and Schuylkill. The meetings will include the opportunity for members of the public to ask questions and fill out a survey.
The treatment under study, PolyHeme, is a universally-compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available. It has been studied in trauma trials in the hospital setting. PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Ill., http://www.northfieldlabs.com
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