Loyola University Health System, a Chicago-based health-care institution recognized for its specialty care and research, plans to test PolyHeme, an investigational oxygen-carrying blood substitute designed to increase survival of critically injured and bleeding trauma patients at the scene of injury, beginning July 1, 2004, as part of a national clinical trial.
Loyola's Institutional Review Board for the Protection of Human Research Subjects (IRB) approved the clinical trial following extensive public education activities.
"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.
"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.
"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, US 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.
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.
"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."
During the study, every effort will be made to receive consent from the patient or the patient's family.
The blood substitute would be assigned to patients on a random basis who would have a 50 percent chance of receiving the substitute vs. the current standard of treatment, which is saline solution or salt water. Loyola's protocol will be that blood substitute will be used on alternating days with saline. The study will compare the survival rate of patients receiving the blood substitute to that of patients who receive saline solution. In previous studies, the substitute has been well-tolerated.
Loyola's IRB, a body responsible for the initial and continuing review and approval of the research, will oversee this study.
Loyola is one of 20 Level I trauma centers participating in the trial nationwide and the only one in Illinois.