UTHSC Physicians Conduct Clinical Trial Study

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Three UTHSC physicians are conducting a clinical trial study to evaluate the effectiveness and safety of a blood substitute in trauma patients.

Three UTHSC physicians, Drs. Timothy C. Fabian, Martin A. Croce and Tiffany K. Bee, are conducting a clinical trial study to evaluate the effectiveness and safety of a blood substitute in trauma patients. Part of a national clinical trial with nineteen other trauma center sites, the doctors will use PolyHeme®, an oxygen-carrying blood substitute, in treating severely injured and bleeding patients. In this controlled study, patients meeting the eligibility criteria will be randomly assigned to receive infusions of either Poly Heme® or the current standard treatment, a saline solution. Treatment will begin before arrival at the hospital, either at the scene of the injury or in the helicopter, and continue during a 12-hour post injury period in the hospital.

Under the direction of the Institutional Review Board (IRB), the Elvis Presley Trauma Center at The Med, recently completed the mandatory process of community notification and consultation in connection with the study. As a result, the IRB has officially approved the Trauma Center as a study site, and hospital staff members have completed the necessary training.

“We are pleased that patient enrollment in this pre-hospital trial with a blood substitute may now begin,” said study investigators, Drs. Timothy C. Fabian, Martin A. Croce, and Tiffany K. Bee. “This is a very important study, and it could potentially lead to a change in the initial treatment of critically injured and bleeding patients that might ultimately result in improved survival.”

According to the investigators, PolyHeme® is expected to be the ideal resuscitative fluid to use because it: supports life without donated blood, is immediately available, universally compatible, has a decreased risk of disease transmission, allows rapid and massive infusion, and has a shelf life of more than one year.

Because patients eligible for the study will not be able to provide consent due to the nature of their injuries, the study is being conducted under a federal regulation that provides an exception from informed consent requirements. Individuals wishing to decline participating in the study for religious or other reasons should contact study coordinator, Stephanie Panzer, RN at 448-5714 to obtain a wristband expressing this choice.