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

This study is currently recruiting participants.
Verified May 2017 by Samuel Tisherman, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042015
First Posted: January 5, 2010
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Samuel Tisherman, University of Maryland
  Purpose
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 Intervention Phase
Cardiac Arrest From Trauma Combination Product: Emergency preservation and resuscitation Other: Standard resuscitation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samuel Tisherman, University of Maryland:

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

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

Estimated Enrollment: 20
Actual Study Start Date: October 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042015


Contacts
Contact: Samuel A Tisherman, MD 410-328-9781 stisherman@umm.edu

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Samuel A Tisherman, MD    410-328-9781    stisherman@umm.edu   
Contact: Leslie Sult, RN    410-328-0288    lsult@stapa.umm.edu   
Sub-Investigator: Thomas Scalea, MD         
Sub-Investigator: Deborah Stein, MD         
Sub-Investigator: Megan Brenner, MD         
Sub-Investigator: James O'Connor, MD         
Sub-Investigator: Joseph Rabin, MD         
Sub-Investigator: Zachary Kon, MD         
Principal Investigator: Samuel A Tisherman, MD         
United States, Pennsylvania
University of Pittsburgh Suspended
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Maryland
University of Pittsburgh
Investigators
Principal Investigator: Samuel A Tisherman, MD University of Maryland
  More Information

Responsible Party: Samuel Tisherman, Professor of Surgery, University of Maryland
ClinicalTrials.gov Identifier: NCT01042015     History of Changes
Other Study ID Numbers: HP-00062740
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: May 3, 2017
Last Verified: May 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Samuel Tisherman, University of Maryland:
trauma
cardiac arrest
hemorrhagic shock

Additional relevant MeSH terms:
Emergencies
Wounds and Injuries
Heart Arrest
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases