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.
"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 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. If there is an objection in advance from the patient or the patient's family, he or she will not receive the blood substitute. Use of the blood substitute can be stopped at anytime during the trial based on patient or family request.
Under the study protocol, treatment will begin before arrival at the hospital, either at the scene of the injury, in the ambulance or in LIFESTAR® (Loyola's helicopter paramedic unit/air ambulance), and continue during a 12-hour post-injury period in the hospital. Because blood is not currently carried in ambulances, the use of the blood substitute in these settings has the potential to address a critical unmet medical need. 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.
During the clinical trial, members of the public may continue to learn about the study and provide feedback by visiting Loyola's Web site: www.luhs.org/bloodsubstitute.
Members of the public who do not want to be enrolled in the study may receive a bracelet stating "I Decline the Northfield PolyHeme® Study." They may call the study hotline, (708) 327-2452 or send an e-mail to: email@example.com.
The study is sponsored by the blood substitute manufacturer, Northfield Laboratories Inc., based in Evanston, Ill.
Loyola's IRB, a body responsible for the initial and continuing review and approval of the research, will oversee this study. Criteria for patients to be enrolled in the study include: patients are in a life-threatening situation requiring emergency medical intervention; currently available treatments are unsatisfactory; potential risks are reasonable; participation in the study could help some patients; and the research could not be practicably conducted without an exception from informed consent requirements.
For more information about the clinical trial or the blood substitute, members of the public may visit: www.luhs.org/bloodsubstitute.
NOTE: A video b-roll package and still photos are available.