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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma

Conditions
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Cardiac Arrest From Trauma

Intervention / Treatment
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* Combination Product: Emergency preservation and resuscitation
* Other: Standard resuscitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concurrent controls<br>These subjects would undergo standard resuscitative efforts. | Other: Standard resuscitation<br>* Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.<br>|
| Experimental: Emergency preservation and resuscitation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). |  | Hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of initiating EPR (cooling and achieving goal brain temperature) |  | 1 hour | 
| Survival |  | 28 days | 
| Neurologic functional outcome |  | 12 months | 
| Multiple organ system dysfunction |  | During the initial hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, cardiac arrest, hemorrhagic shock