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

University of Maryland Baltimore (UMB)

Status and phase: Terminated; Phase 2

Conditions: Cardiac Arrest From Trauma

Treatments: Combination Product: Emergency preservation and resuscitation; Other: Standard resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01042015

HP-00062740

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Concurrent controls

Active Comparator group

Description:

These subjects would undergo standard resuscitative efforts.

Treatment:

Other: Standard resuscitation

Emergency preservation and resuscitation

Experimental group

Description:

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

Treatment:

Combination Product: Emergency preservation and resuscitation