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

Cardiac Arrest From Trauma Clinical Trial

— EPR-CAT  

Official title:

Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01042015
• Other study ID #: HP-00062740
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Maryland, Baltimore
• Contact: Samuel A Tisherman, MD
• Phone: 410-328-9781
• Email: stisherman[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest From Trauma
• Emergencies
• Heart Arrest
• Wounds and Injuries

Intervention

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.

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

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Cook County Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).		Hospital discharge
Secondary	Feasibility of initiating EPR (cooling and achieving goal brain temperature)		1 hour
Secondary	Survival		28 days
Secondary	Neurologic functional outcome		12 months
Secondary	Multiple organ system dysfunction		During the initial hospitalization