Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma (EPR-CAT)
|Cardiac Arrest From Trauma||Combination Product: Emergency preservation and resuscitation Other: Standard resuscitation||Phase 2|
|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|
- The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). [ Time Frame: Hospital discharge ]
- 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 ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042015
|Contact: Samuel A Tisherman, MDemail@example.com|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Samuel A Tisherman, MD 410-328-9781 firstname.lastname@example.org|
|Contact: Leslie Sult, RN 410-328-0288 email@example.com|
|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|
|Principal Investigator:||Samuel A Tisherman, MD||University of Maryland|