Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Samuel A Tisherman, MD
410-328-9781
stisherman@som.umaryland.edu

More Details

NCT ID
NCT01042015
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Samuel A Tisherman, MD
410-328-9781
stisherman@som.umaryland.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.