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

NCT01042015 | Terminated Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: HP-00062740
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest From Trauma

Keywords

trauma; cardiac arrest; hemorrhagic shock

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).

  Hospital discharge

Secondary Outcomes (4)

• Feasibility of initiating EPR (cooling and achieving goal brain temperature)

  1 hour

• Survival

  28 days

• Neurologic functional outcome

  12 months

• Multiple organ system dysfunction

  During the initial hospitalization

Study Arms (2)

Concurrent controls

ACTIVE COMPARATOR

These subjects would undergo standard resuscitative efforts.

Other: Standard resuscitation

Emergency preservation and resuscitation

EXPERIMENTAL

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

Combination Product: Emergency preservation and resuscitation

Interventions

Emergency preservation and resuscitation 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.

Emergency preservation and resuscitation

Standard resuscitation OTHER

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

Concurrent controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Cook County Health: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 28538639 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Heart Arrest; Shock, Hemorrhagic

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Officials

• Samuel A Tisherman, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: October 1, 2016
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)