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

NCT ID: NCT01042015

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2025-11-21

Brief 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.

Detailed 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.

Conditions

Cardiac Arrest From Trauma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent controls

These subjects would undergo standard resuscitative efforts.

Group Type: ACTIVE_COMPARATOR

Standard resuscitation

Intervention Type: OTHER

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

Emergency preservation and resuscitation

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

Group Type: EXPERIMENTAL

Emergency preservation and resuscitation

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Standard resuscitation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Samuel Tisherman

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel A Tisherman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28538639 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HP-00062740

Identifier Type: -

Identifier Source: org_study_id