Duke University Hospital Press Release
Patients could become the subject of the study if they arrive at Duke in a life-threatening state. The trial will only affect people transported to the hospital by Durham Emergency Medical Services ambulances. Children, pregnant women and head trauma victims will not get the synthetic blood.
"This is a groundbreaking clinical trial for a much-needed blood substitute and we're very pleased to be involved," said Steven Vaslef, M.D., medical director of the Duke Trauma Center and lead investigator at the Duke study site. "Traumatic injury is a leading cause of death in Americans, but no one expects to be injured. It is vitally important to treat trauma patients as early as possible. The treatment process typically begins at the scene of injury, so if PolyHeme proves to be effective, having the ability to use it to provide treatment with an oxygen-carrying solution means we'll be better able to keep their hemoglobin levels up and increase their likelihood for survival."
A 1996 Food and Drug Administration ruling eliminates the need for patient consent in specific trials that involve emergency situations and life-saving techniques.
If you do not want to take part in the trial, you can call
with "PolyHeme" or "Opt Out" in the subject line.
You may also write a letter to Dr. Steven Vaslef, DUMC Box 2601, Duke University Medical Center, Durham, N.C. 27710.
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