Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma
The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.
- Cardiac Arrest From Trauma
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Penetrating trauma with clinical suspicion of exsanguinating hemorrhage
- At least 1 sign of life at the scene (pulse, respiratory efforts, spontaneous movements, reactive pupils)
- Loss of pulse <5 min prior to Emergency Department (ED) arrival or in ED or operating room
- ED thoracotomy performed without immediate return of a palpable pulse in the carotid arteries after clamping the descending thoracic aorta
- No signs of life for >5 min prior to the decision to initiate EPR
- Obvious non-survivable injury
- Suggestion of traumatic brain injury, such as significant facial or cranial distortion
- Electrical asystole
- Rapid external assessment of the injuries suggests massive tissue trauma or blunt trauma involving multiple body regions
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|These subjects would undergo standard resuscitative efforts.||
Emergency preservation and resuscitation
|These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass.||
- NCT ID
- University of Maryland, Baltimore
Study ContactSamuel A Tisherman, MD
The intent of the technique to be studied is to induce a state of hypothermic preservation in trauma victims who have exsanguinated to the point of cardiac arrest. In appropriately selected subjects, after an initial emergency attempt at resuscitation with standard techniques, an arterial catheter will be inserted into the descending thoracic aorta. Using appropriate tubing, pump, and heat exchanger,a large quantity of ice-cold saline (0.9% Sodium Chloride for Injection USP) will be pumped as rapidly as possible into the aorta with the goal of cooling the brain (tympanic membrane temperature, Tty) to <10 C. If possible, a large venous catheter will be placed and recirculation of fluid established.
Once the subject has been sufficiently cooled, bleeding will be controlled surgically. The subject will then be resuscitated and rewarmed with full cardiopulmonary bypass.
The goal is to improve neurologically-intact survival in these patients.