Clinical trial NCT01042015: Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma
Official title: Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiac Arrest From Trauma
Keywords: trauma
cardiac arrest
hemorrhagic shock
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Cook County Health
First posted: 2010-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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 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

Primary outcomes:
measure: The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).
timeFrame: Hospital discharge
Secondary outcomes:
measure: Feasibility of initiating EPR (cooling and achieving goal brain temperature)
timeFrame: 1 hour
measure: Survival
timeFrame: 28 days
measure: Neurologic functional outcome
timeFrame: 12 months
measure: Multiple organ system dysfunction
timeFrame: During the initial hospitalization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Samuel A Tisherman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tisherman SA, Alam HB, Rhee PM, Scalea TM, Drabek T, Forsythe RM, Kochanek PM. Development of the emergency preservation and resuscitation for cardiac arrest from trauma clinical trial. J Trauma Acute Care Surg. 2017 Nov;83(5):803-809. doi: 10.1097/TA.0000000000001585.