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

• ClinicalTrials.gov Identifier: NCT01042015
• Recruitment Status: Recruiting
• First Posted: January 5, 2010
• Last Update Posted: December 13, 2022
• Sponsor: University of Maryland, Baltimore
• Collaborator: John H. Stroger Hospital
• Information provided by (Responsible Party): Samuel Tisherman, University of Maryland, Baltimore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest From Trauma	Combination Product: Emergency preservation and resuscitation; Other: Standard resuscitation	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
• Actual Study Start Date: October 2016
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Feasibility of initiating EPR (cooling and achieving goal brain temperature) [ Time Frame: 1 hour ]
2. Survival [ Time Frame: 28 days ]
3. Neurologic functional outcome [ Time Frame: 12 months ]
4. Multiple organ system dysfunction [ Time Frame: During the initial hospitalization ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Samuel A Tisherman, MD; 410-328-9781; stisherman@som.umaryland.edu

Contact: Leslie Sult; 410-299-3738; lsult@som.umaryland.edu

Locations

United States, Illinois

Stroger Hospital of Cook County; Not yet recruiting

Chicago, Illinois, United States, 60612

Contact: Faran Bokhari, MD 312-864-2741 fbokhari2000@yahoo.com

United States, Maryland

University of Maryland; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Samuel A Tisherman, MD 410-328-9781 stisherman@som.umaryland.edu

Contact: Leslie Sult, RN 410-328-0288 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

Sponsors and Collaborators

University of Maryland, Baltimore

John H. Stroger Hospital

Investigators

• Principal Investigator: Samuel A Tisherman, MD; University of Maryland, Baltimore

  Study Documents (Full-Text)

Documents provided by Samuel Tisherman, University of Maryland, Baltimore:

Study Protocol  [PDF] April 26, 2016

More Information

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.

• Responsible Party: Samuel Tisherman, Professor of Surgery, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01042015
• Other Study ID Numbers: HP-00062740
• First Posted: January 5, 2010
• Last Update Posted: December 13, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Samuel Tisherman, University of Maryland, Baltimore:

trauma; cardiac arrest; hemorrhagic shock

Additional relevant MeSH terms:

Heart Arrest; Emergencies; Wounds and Injuries; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases