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Trial record 1 of 1 for:    emergency preservation and resuscitation
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Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma (EPR-CAT)

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ClinicalTrials.gov Identifier: NCT01042015
Recruitment Status : Recruiting
First Posted : January 5, 2010
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
John H. Stroger Hospital
Information provided by (Responsible Party):
Samuel Tisherman, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 5, 2010
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). [ Time Frame: Hospital discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • Feasibility of initiating EPR (cooling and achieving goal brain temperature) [ Time Frame: 1 hour ]
  • Survival [ Time Frame: 28 days ]
  • Neurologic functional outcome [ Time Frame: 6 months ]
  • Multiple organ system dysfunction [ Time Frame: During the initial hospitalization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma
Official Title  ICMJE Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest From Trauma
Intervention  ICMJE
  • 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.
  • Other: Standard resuscitation
    Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.
Study Arms  ICMJE
  • Active Comparator: Concurrent controls
    These subjects would undergo standard resuscitative efforts.
    Intervention: Other: Standard 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.
    Intervention: Combination Product: Emergency preservation and resuscitation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samuel A Tisherman, MD 410-328-9781 stisherman@som.umaryland.edu
Contact: Leslie Sult 410-299-3738 lsult@som.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042015
Other Study ID Numbers  ICMJE HP-00062740
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samuel Tisherman, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE John H. Stroger Hospital
Investigators  ICMJE
Principal Investigator: Samuel A Tisherman, MD University of Maryland, Baltimore
PRS Account University of Maryland, Baltimore
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP