TerminatedPhase 2

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

Stopped: Enrollment was too slow with little potential for success. The complexities and resources needed for the intervention outweigh the very low probability of benefiting a rare patient. The DSMB and investigators agreed to terminate the study.

United States20 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has been terminated, can you tell me why it was stopped early, and whether that affects how we should interpret any data that was collected?
2This trial was testing Emergency Preservation and Resuscitation for traumatic cardiac arrest — is there any published evidence from this study that might inform how my care team would approach my treatment right now?
3The trial measured survival without major disability using a specific scale called the Glasgow Outcome Scale-Extended — based on what you know about this research, what outcomes were actually being seen for patients in similar situations?
4Since this was a Phase 2 trial, meaning it was still in relatively early stages of testing safety and effectiveness, are there other completed or ongoing studies on traumatic cardiac arrest that might give us more established guidance?
5Given that this trial is no longer enrolling, what are the current standard-of-care options for traumatic cardiac arrest that my care team would use instead?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).

Timeframe: Hospital discharge

Trial details

NCT IDNCT01042015

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-21

View on ClinicalTrials.gov More Cardiac Arrest From Trauma trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.