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

Last updated: February 9, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Standard resuscitation

Emergency preservation and resuscitation

Clinical Study ID

NCT01042015
HP-00062740
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Penetrating trauma with clinical suspicion of exsanguinating hemorrhage

  • At least 1 sign of life at the scene (pulse, respiratory efforts, spontaneousmovements, reactive pupils)

  • Loss of pulse <5 min prior to Emergency Department (ED) arrival or in ED oroperating room

  • ED thoracotomy performed without immediate return of a palpable pulse in the carotidarteries after clamping the descending thoracic aorta

Exclusion

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 cranialdistortion

  • Electrical asystole

  • Rapid external assessment of the injuries suggests massive tissue trauma or blunttrauma involving multiple body regions

  • Pregnancy

  • Prisoners

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Standard resuscitation
Phase: 2
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Stroger Hospital of Cook County

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15261
    United States

    Site Not Available

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