Trial of Body Cooling For Cardiac Arrest From Massive Bleeding to Begin in Early 2012
Public Comment Sought for Waiver-of-Informed Consent Process
PITTSBURGH, Nov. 15, 2011 - Trauma experts at the University of Pittsburgh School of Medicine and UPMC will be launching a multi-center trial to see if they can rescue patients who have suffered cardiac arrest due to massive bleeding by chilling them to nearly 50 degrees below normal body temperature.
Because individuals likely will not be able to learn about and consent to participation when they sustain these severe injuries, the Emergency Preservation and Resuscitation For Cardiac Arrest From Trauma (EPR-CAT) study will be conducted under a federally authorized exception-from-informed consent process that includes opportunities for public comment and a means to opt out of inclusion. The research protocol will be performed at UPMC Presbyterian and at the R Adams Cowley Shock Trauma Center, University of Maryland.
The first two town hall meetings, in which researchers will describe the study and answer questions, will be conducted on Dec. 7 and Dec. 8 at noon, Room 527, William Pitt Union, Oakland. More information can be found at www.acutecareresearch.org.
Sponsored by the U.S. Department of Defense, the University of Pittsburgh and UPMC, the EPR-CAT study builds on findings that therapeutic hypothermia, or body cooling, improves survival in non-trauma cardiac arrest patients, explained principal investigator Samuel Tisherman, M.D., professor of critical care medicine and surgery, Pitt School of Medicine, and associate director of the Safar Center for Resuscitation Research at Pitt.
“In that group of patients, blood loss was not the reason why the heart stopped beating,” he explained. “But when blood loss is the cause of cardiac arrest, restarting the heart does little good if the bleeding is not under control. The brain can be permanently damaged if it doesn’t get sufficient oxygen for more than a few minutes even if the rest of the resuscitation is successful. ”
Rapid cooling might be able to sustain the patient – particularly the brain – long enough to “buy time” to find and treat the source of blood loss, Dr. Tisherman said. In EPR, body temperature is lowered to about 50 degrees Fahrenheit by administering a large volume of cold fluid through a large tube, called a cannula, placed into the aorta, which is the largest artery in the body. A heart-lung bypass machine would be used to restore blood circulation and oxygenation as part of the resuscitation process.
Trauma, such as car accidents and gunshot wounds, causes more than 150,000 deaths annually in the United States. Standard care includes the rapid administration of intravenous fluids and blood products. If the patient suffers a cardiac arrest, surgeons may open the left side of the chest to perform open cardiopulmonary resuscitation (CPR) and attempt to quickly repair the injuries. Despite these efforts, fewer than 10% of patients who suffer a cardiac arrest from trauma survive.
To be eligible for this study, individuals must have suffered a cardiac arrest from trauma, presumably from rapid hemorrhage or bleeding. Due to the severity of the injuries and need for rapid treatment, physicians will not be able to obtain informed consent, as is typically required in research studies, from the patients on whom these measures will be tested nor from the patients’ next-of-kin.
Instead, the EPR-CAT study, which has been reviewed by government agencies and university research review boards, will be conducted under the federally regulated exception-from-informed consent process, which includes appropriate community consultation and public notification.
Other times and locations of forums in which community members can learn more about the study and ask questions about it can be found at acutecareresearch.org. Community members who do not wish to participate in these research studies can obtain a bracelet to opt out by going to that website or contacting Tina Vita at 412-647-9652.
Follow this hyperlink to view a brief interview with Dr. Samuel Tisherman and a simulation of the EPR-CAT protocol.