Northfield Laboratories Reports Preliminary Top-Line Data In Pivotal Phase III Trauma Study! Read more... Trauma-related injuries are a leading cause of death in Americans under 45 years old, affecting more than 2 million persons annually. Nearly one in five trauma victims dies as a result of his/her injuries.
The University of Cincinnati Medical Center is one of a select number of Level I trauma centers in the U.S. chosen to participate in a groundbreaking national clinical trial to evaluate the safety and efficacy of PolyHemeŽ, an oxygen-carrying blood substitute, in increasing survival of 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 ambulance, and continue during a 12-hour post injury period in the hospital. Since blood is not presently carried in ambulances, the use of PolyHeme in these settings has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is currently not available. The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution.
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 extensively in trauma trials in the hospital setting. PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Illinois.
In this trial it may not be possible to obtain informed consent from the patient or a legally authorized representative due to the urgency of the situation and the extent of the injuries. The study is therefore being conducted under a federal regulation that allows research to be conducted in certain emergent, life-threatening situations using an exception from the requirement for informed consent. Only persons over 18 years of age who meet specific study criteria will be eligible for inclusion.
The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution.
Principal Investigator
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Study Sponsor
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