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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University of Pittsburgh
Sponsor:
Collaborators:
University of Maryland
University of Pennsylvania
Massachusetts General Hospital
University of Arizona
Oregon Health and Science University
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01042015
First received: January 4, 2010
Last updated: August 13, 2014
Last verified: August 2011
  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
Device: Emergency preservation and resuscitation
Other: Standard resuscitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Pittsburgh:

Primary Outcome Measures:
  • The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of initiating EPR (cooling and achieving goal brain temperature) [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Neurologic functional outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Multiple organ system dysfunction [ Time Frame: During the initial hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Primary Completion Date: December 2016 (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.
Device: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042015

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

Locations
United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Peter Rhee, MD    520-626-5095    prhee@surgery.arizona.edu   
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Thomas Scalea, MD    410-328-8976    tscalea@umm.edu   
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Martin Schreiber, MD    503-494-5300    schreibm@ohsu.edu   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Raquel Forsythe, MD    412-647-3065    forsytherm@upmc.edu   
Principal Investigator: Raquel Forsythe, MD         
Sub-Investigator: Louis Alarcon, MD         
Sub-Investigator: Jason Sperry, MD         
Sub-Investigator: Christian Bermudez, MD         
Sub-Investigator: Patrick Kochanek, MD         
Sponsors and Collaborators
University of Pittsburgh
University of Maryland
University of Pennsylvania
Massachusetts General Hospital
University of Arizona
Oregon Health and Science University
Investigators
Principal Investigator: Samuel A Tisherman, MD University of Maryland
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01042015     History of Changes
Other Study ID Numbers: W81XWH-07-1-0682
Study First Received: January 4, 2010
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
trauma
cardiac arrest
hemorrhagic shock

Additional relevant MeSH terms:
Heart Arrest
Wounds and Injuries
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014