Cooling trauma victims with cardiac arrest to improve survival
Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
This study tests if quickly cooling trauma patients who have had a cardiac arrest from severe bleeding can help them survive better and keep their brain function intact.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT01042015 on ClinicalTrials.gov |
What this trial studies
This study aims to rapidly cool trauma patients who have experienced cardiac arrest due to severe bleeding. The approach involves administering ice-cold sodium chloride directly into the aorta to induce hypothermic preservation, allowing for surgical control of bleeding. After cooling, patients will undergo resuscitation and rewarming using cardiopulmonary bypass. The ultimate goal is to enhance the chances of neurologically intact survival in these critically injured individuals.
Who should consider this trial
Good fit: Ideal candidates are trauma victims with signs of life who have suffered cardiac arrest due to exsanguinating hemorrhage.
Not a fit: Patients who have been without signs of life for more than 5 minutes or have non-survivable injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve survival rates and neurological outcomes for trauma patients experiencing cardiac arrest from hemorrhagic shock.
How similar studies have performed: While this approach is innovative, similar techniques in emergency preservation and resuscitation have shown promise in preliminary studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Samuel A Tisherman, MD — University of Maryland, Baltimore
- Study coordinator: Samuel A Tisherman, MD
- Email: stisherman@som.umaryland.edu
- Phone: 410-328-9781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.