Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma - Full Text View

Sponsor:	University of Pittsburgh
Collaborators:	University of Maryland University of Pennsylvania Massachusetts General Hospital University of Arizona Oregon Health and Science University
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01042015

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	Other: Emergency preservation and resuscitation Other: Standard resuscitation	Phase II

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:

MedlinePlus related topics: Cardiac Arrest Injuries Wounds

U.S. FDA Resources

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 2014 (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.	Other: 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 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

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

Contacts

Contact: Samuel A Tisherman, MD

412-647-8410

tishermansa@upmc.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, Massachusetts
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Hasan Alam, MD 617-643-2433 hbalam@partners.org
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 Pennsylvania	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Babak Sarani, MD 215-662-7323 saranib@uphs.upenn.edu
University of Pittsburgh	Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Samuel A Tisherman, MD 412-647-8410 tishermansa@upmc.edu

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 Pittsburgh

More Information

No publications provided

Responsible Party:	Samuel A. Tisherman, MD, 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 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

trauma
cardiac arrest
hemorrhagic shock

Additional relevant MeSH terms:

Emergencies
Heart Arrest
Wounds and Injuries
Disease Attributes

Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012