Loyola's Institutional Review Board for the Protection of Human Research Subjects (IRB) approved the clinical trial following extensive public education activities. Since February, Loyola has been conducting a number of community outreach efforts, including meetings with community leadership; open forums with members of the public; placing public notices in community newspapers; and distributing flyers in schools, churches, grocery stores and public health centers. Loyola is one of 20 Level I trauma centers participating 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.
The community outreach efforts were necessary in this study because the nature of the potential patients' injuries extreme shock would typically prevent having informed consent. However, consent will be sought whenever possible.
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.