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

Phase 2TerminatedNCT01042015

University of Maryland, Baltimore20 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Arrest From Trauma

Interventions

Emergency preservation and resuscitationCOMBINATION_PRODUCT

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.

Standard resuscitationOTHER

Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).

Time frame: Hospital discharge

Secondary Outcomes

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

Data from ClinicalTrials.gov

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