Cardiac Arrest From Trauma
Conditions
Keywords
trauma, cardiac arrest, hemorrhagic shock
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.
Interventions
COMBINATION_PRODUCTEmergency 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.
OTHERStandard resuscitation
Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.
Sponsors
University of Maryland, Baltimore
Cook County Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). | Hospital discharge |
Secondary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSamuel A Tisherman, MD
University of Maryland, Baltimore
Outcome results
None listed