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

Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest From Trauma
• Intervention / Treatment: Other: Standard resuscitation; Combination product: Emergency preservation and resuscitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Samuel A Tisherman, MD; Phone Number: 410-328-9781; Email: stisherman@som.umaryland.edu
• Study Contact Backup: Name: Leslie Sult; Phone Number: 410-299-3738; Email: lsult@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Samuel A Tisherman, MD; Phone Number: 410-328-9781; Email: stisherman@som.umaryland.edu
      • Contact: Leslie Sult, RN; Phone Number: 410-328-0288; Email: lsult@som.umaryland.edu
      • Sub-Investigator: Thomas Scalea, MD
      • Sub-Investigator: James O'Connor, MD
      • Sub-Investigator: Joseph Rabin, MD
      • Principal Investigator: Samuel A Tisherman, MD
      • Sub-Investigator: Kristopher Deatrick, MD
      • Sub-Investigator: David Efron, MD
      • Sub-Investigator: Rishi Kundi, MD
      • Sub-Investigator: Deborah Stein, MD
      • Sub-Investigator: Yvonne Chung, MD
      • Sub-Investigator: Douglas Anderson, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concurrent controls; These subjects would undergo standard resuscitative efforts.	Other: Standard resuscitation; Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.
Experimental: Emergency preservation and resuscitation; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival	28 days
Feasibility of initiating EPR (cooling and achieving goal brain temperature)	1 hour
Neurologic functional outcome	12 months
Multiple organ system dysfunction	During the initial hospitalization

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Cook County Health
• Investigators: Principal Investigator: Samuel A Tisherman, MD, University of Maryland, Baltimore

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimated): January 5, 2010

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: trauma; cardiac arrest; hemorrhagic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Wounds and Injuries; Heart Arrest
• Other Study ID Numbers: HP-00062740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes