MedTrace Logo

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

NCT01042015 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-17

No results posted yet for this 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.

Conditions

  • Cardiac Arrest From Trauma

Interventions

COMBINATION_PRODUCT

Emergency preservation and resuscitation

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.

OTHER

Standard resuscitation

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

Sponsors & Collaborators

  • Cook County Health

    collaborator OTHER_GOV

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Samuel A Tisherman, MD · University of Maryland, Baltimore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2025-11-21
Completion
2025-11-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042015 on ClinicalTrials.gov