Cardiac Arrest From TraumaPhase 2EPR-CATNCT01042015
Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma
A Phase 2 study testing Emergency preservation and resuscitation and Standard resuscitation in people with Cardiac Arrest From Trauma, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest From Trauma
- What is being tested?
- Emergency preservation and resuscitation and Standard resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 21 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
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.
Read the 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.
- Conditions
- Cardiac Arrest From Trauma
- Being tested
- Emergency preservation and resuscitation, Standard resuscitation
- Keywords
- trauma, cardiac arrest, hemorrhagic shock
- Medical subject headings
- Wounds and Injuries, Heart Arrest, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency preservation and resuscitationCombination product
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.
Standard resuscitationOther
Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent controls | Active comparator | These subjects would undergo standard resuscitative efforts. Receives: Other: Standard resuscitation |
| Emergency preservation and resuscitation | Experimental | These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass. Receives: Combination Product: Emergency preservation and resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).
Measured: Hospital discharge
Secondary outcomes (4)
Feasibility of initiating EPR (cooling and achieving goal brain temperature)
Measured: 1 hour
Survival
Measured: 28 days
Neurologic functional outcome
Measured: 12 months
Multiple organ system dysfunction
Measured: During the initial hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startOct 2016
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest From TraumaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Cook County Health
- Responsible party
- Principal investigator, Samuel Tisherman, University of Maryland, Baltimore
- Investigators
- Samuel A Tisherman, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042015
- Sponsor's protocol ID
- HP-00062740
- Acronym
- EPR-CAT
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2010
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28538639
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma
- ClinicalTrials.gov ID
- NCT01042015
- Acronym / sponsor ID
- EPR-CAT / HP-00062740
- Conditions
- Cardiac Arrest From Trauma
- Keywords
- trauma, cardiac arrest, hemorrhagic shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Cook County Health
- Study start
- Oct 2016 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent controls | Active comparator | Other: Standard resuscitationThese subjects would undergo standard resuscitative efforts. |
| Emergency preservation and resuscitation | Experimental | Combination Product: Emergency preservation and resuscitationThese subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency preservation and resuscitationThis 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. | Combination product | Emergency preservation and resuscitation |
| Standard resuscitationStandard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation. | Other | Concurrent controls |
Primary outcome
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).
Time frame: Hospital discharge
4 secondary outcomes
Feasibility of initiating EPR (cooling and achieving goal brain temperature)
Time frame: 1 hour
Survival
Time frame: 28 days
Neurologic functional outcome
Time frame: 12 months
Multiple organ system dysfunction
Time frame: During the initial hospitalization
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 28538639Tisherman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A Tisherman, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emergency preservation and resuscitation and Standard resuscitation in people with Cardiac Arrest From Trauma, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). (time frame: Hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.