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

  • STATUS
    Recruiting
  • End date
    Dec 8, 2023
  • participants needed
    20
  • sponsor
    University of Maryland, Baltimore
Updated on 8 July 2022

Summary

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.

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.

Details
Condition Cardiac Arrest From Trauma
Treatment Emergency preservation and resuscitation, Standard resuscitation
Clinical Study IdentifierNCT01042015
SponsorUniversity of Maryland, Baltimore
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

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
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