In order to receive approval for the field component of this clinical trial, U.S. Food and Drug Administration regulations and Loyola's IRB require evidence that broad public notification has been made to ensure members of the public have an opportunity to share their concerns. In addition to the community outreach efforts, members of the public had the opportunity to provide feedback on the Web, via e-mail, through a dedicated phone line, and in-person at eight community meetings.
Loyola will use the blood substitute in some patients on its LIFESTAR aeromedical unit and in the Illinois communities of Berwyn, Hillside and Northlake, which participate in Loyola's Emergency Medical Services (EMS) network. These communities have extensive experience with trauma because of their proximity to major highways. Loyola's LIFESTAR staff (paramedic and/or nurse) will administer the blood substitute to victims of motor vehicle crashes on major Chicago-area highways or other trauma situations.
"Getting an oxygen-carrying blood substitute into our patients at the scene of injury could increase their chance of survival," said Gamelli. "Right now, one in five Americans die of trauma-related injuries, which are the leading cause of death for Americans under the age of 45."
The public notification activities were required because trauma patients, given the nature and extent of their injuries, are unable to give consent after an injury, such as a motor vehicle crash. During the study, every effort will be made to receive consent from the patient or the patient's family.
'"/>
Contact: Stephen Davidow
sdavidow@lumc.edu
708-216-8232
Loyola University Health System
27-May-2004