Loyola University Health System begins today the national clinical trial using PolyHeme®, an investigational oxygen-carrying blood substitute designed to increase survival of critically injured and bleeding trauma patients at the scene of injury. Loyola has been involved in extensive public education, staff education and paramedic training since its Institutional Review Board for the Protection of Human Research Subjects (IRB) approved the clinical trial in May. Loyola is one of 20-25 Level I trauma centers which will participate in the trial nationwide and the only one in Illinois.
“If the blood substitute works the way we hope it will, it could be the first major advance since the introduction of saline, or salt water, to replace volume after blood loss, around the time of World War I,” said Dr. Richard L. Gamelli, principal investigator, chair of the Department of Surgery and professor of trauma surgery, Loyola University Chicago Stritch School of Medicine. Currently, patients can only receive blood in a hospital and that means a trauma victim may need to wait up to an hour for a transfusion following transport to the hospital and being typed and cross-matched. “Saline, the current standard of care, helps us restore a patient’s blood pressure but does not deliver oxygen, a critical nutrient to prevent organ damage in the brain, heart, lungs, liver and kidneys,” Gamelli explained. “Carrying blood in an ambulance isn’t practical because it needs to be refrigerated, has a short shelf life and needs to be typed and cross-matched to the specific patient. In contrast, the blood substitute carries oxygen, has a long shelf life and is compatible with all blood types,” said Gamelli, who also is chief of Loyola’s Burn Center and director of Loyola’s Burn and Shock Trauma Institute.
In order to receive approval for the field component of this clinical trial, U.S. Food and Drug Administration regulations and Loyola’s IRB required 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.
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