Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma (EPR-CAT)

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.

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.

These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass.

This involves the induction of profound hypothermia using a flush of ice-cold saline into the aorta. Once hypothermia is achieved, the subject would undergo rapid operative interventions to control bleeding followed by resuscitation/rewarming with cardiopulmonary bypass.

Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.

The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).

Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnancy Prisoners

Tisherman SA, Alam HB, Rhee PM, Scalea TM, Drabek T, Forsythe RM, Kochanek PM. Development of the emergency preservation and resuscitation for cardiac arrest from trauma clinical trial. J Trauma Acute Care Surg. 2017 Nov;83(5):803-809. doi: 10.1097/TA.0000000000001585.