Shock Trauma to Study Body Cooling for Patients in Cardiac Arrest from Massive Bleeding

Multi-Site Clinical Study Aims to Improve Current 5 Percent Survival Rate

BALTIMORE, October 14, 2016—The R Adams Cowley Shock Trauma Center at the University of Maryland has opened a clinical trial to study whether rapidly cooling the body temperature of patients whose hearts stop due to massive blood loss will give surgeons extra time to find and repair injuries, and in turn, help save their lives. The trial, funded by the U.S. Department of Defense, builds on previous findings that therapeutic hypothermia improves survival in non-trauma cardiac arrest patients.

Few patients — less than 5 percent — typically survive cardiac arrest due to massive blood loss. The Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT) study will test whether cooling patients' body temperatures to 50 degrees Fahrenheit is safe and can improve outcomes.

"If we can increase the odds so that just 10 percent of these patients survive, that would be a significant achievement," says Thomas M. Scalea, MD, FACS, MCCM, the Honorable Francis X. Kelly Distinguished Professor of Trauma Surgery at the University of Maryland School of Medicine (UM SOM), Physician-in-Chief of the R Adams Cowley Shock Trauma Center, and one of the study's investigators at the University of Maryland. "It's incredibly frustrating because these patients are usually young and otherwise healthy, and we can't save them."

Why Use Therapeutic Hypothermia?

While cardiopulmonary resuscitation (CPR) can save the lives of patients who suffer a non-traumatic cardiac arrest, CPR does little good if bleeding cannot be stopped and there is little to no blood to circulate. Cooling patients to 50 degrees Fahrenheit may buy surgeons extra time to find and repair injuries while protecting the brain and other vital organs from permanent damage.

Organs like the heart and brain need oxygen and blood flow to function. Rapid cooling can decrease the need for oxygen, explains Samuel A. Tisherman, MD, Professor of Surgery and Director of the Division of Critical Care and Trauma Education at UM SOM, and the principal investigator of the multi-center study. Dr. Tisherman is internationally-recognized for developing innovative ways to treat hemorrhagic shock and cardiac arrest using therapeutic hypothermia. EPR-CAT is a continuation of the pioneering work of his mentor Dr. Peter Safar, the father of cardiopulmonary resuscitation.

"With its extensive history and expertise in trauma and critical care research, Shock Trauma is a natural institution to conduct this important trial," Dr. Tisherman says. He adds that while the overall percentage of patients whom Shock Trauma is able to save is very high — around 96 percent — this trial seeks to improve the survival rate of a patient population whose odds are much more dismal.

"Our dedicated faculty are motivated every day to find innovative ways to save lives and advance trauma research," says UM SOM Dean E. Albert Reece, MD, PhD, MBA, Vice President for Medical Affairs at the University of Maryland and the John Z. and Akiko Bowers Distinguished Professor at UM SOM. "With this trial, we are hopeful to improve the outcomes for patients who now have little chance at survival."

How EPR-CAT Works

Patients who experience cardiac arrest after a penetrating trauma, such as a gunshot or stab wound, will be eligible to be enrolled in the study once standard resuscitation techniques have failed. A large volume of cold fluid will be administered through a tube placed directly into the bloodstream. Once the source of the bleeding has been found and repaired, a heart-lung bypass machine will be used to restore blood circulation and warm the body back up.

Due to the severity of injuries required to be eligible for the study and the need for immediate treatment, eligible patients are unable to provide consent to participate. As such, the EPR-CAT study is being conducted under federal guidelines for exception from informed consent. In October 2015, the research team began what is known as community consultation, during which members of the research team discussed the study and fielded questions at several venues throughout Baltimore. Community members are able to provide feedback as well as opt out of the study by obtaining a bracelet.

Upon completion of the community consultation process, the research team reported back to the University of Maryland's Institutional Review Board to seek regulatory approval to begin enrolling patients. The required regulatory approval has now been granted, and treatment teams may begin enrolling eligible patients. Results will be reported only upon the trial's conclusion.

Community members with questions about the study or who wish to obtain an opt-out bracelet may continue to do so by contacting UM SOM Clinical Research Nurse Leslie Sult at 410-328-3272 or lsult@stapa.umm.edu. They can also visit the study website at www.eprstudy.com.

DISCLOSURE:

Dr. Tisherman has a financial interest in intellectual property for the development of the emergency preservation and resuscitation (EPR) procedure and some of the associated hardware including special catheters and accessories which have been licensed to EPR Technologies. This project has been carefully reviewed to ensure that patients' well-being supersedes study results.

About the R Adams Cowley Shock Trauma Center

The R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center was the first fully integrated trauma center in the world, and remains at the epicenter for trauma research, patient care, and teaching, both nationally and internationally today. Shock Trauma is where the "golden hour" concept of trauma was born and where many of the life-saving practices in modern trauma medicine were pioneered. Shock Trauma is also at the heart of Maryland's unparalleled Emergency Medical Service System.

About the University of Maryland School of Medicine

The University of Maryland School of Medicine, chartered in 1807 as the first public medical school in the United States, continues today as a leader in accelerating innovation and discovery in medicine. The School of Medicine is the founding school of the University of Maryland, and is an integral part of the 11-campus University System of Maryland. Located on the University of Maryland's Baltimore campus, the School of Medicine works closely with the University of Maryland Medical Center and Medical System to provide a research-intensive, academic and clinically based education. With 43 academic departments, centers and institutes and a faculty of more than 3,000 physicians and research scientists, plus more than $400 million in extramural funding, the School is regarded as one of the leading biomedical research institutions in the U.S.A., with top-tier faculty and programs in vaccine development, cancer, brain science, surgery and transplantation, trauma and emergency medicine, and human genomics, among other centers of excellence. The School is not only concerned with the health of the citizens of Maryland and the U.S.A., but also has a global presence, with research and treatment facilities in more than 35 countries around the world. For more information, visit http://medschool.umaryland.edu.