Cardiac Arrest, Out-Of-HospitalACEP-V2NCT06603649
Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- ECPR for out-of-hospital cardiac arrest
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients presenting with refractory out-of-hospital cardiac arrest and enrolled in the ECPR program in Nancy, France. Inclusion criteria for the ECPR program are the following: * Age: 18-65 years * No major comorbidity * Witnessed non traumatic cardiac arrest * Low-flow to ECPR estimated of less than 60 minutes
Who may be able to join
- Out-of-hospital cardiac arrest
- enrolled in the ECPR program
- 18 years old or more
- Low-flow estimated <60minutes
Who cannot join
- traumatic cardiac arrest
- major comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Updated Procedure for the Management of Refractory Out-of-hospital Cardiac Arrests with SAMU 54 : the Revised ACEP Protocol in 02/2024
ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. This led to an over-selection of patients and a significant reduction in the number of eligible patients. A balance needed to be struck between over-selecting patients and maintaining the expertise of medical and paramedical teams in the field. In addition, it has also been shown that ECPR also increases the number of organs and transplants.
In February 2024, the criteria for inclusion in the protocol were redefined to include any witnessed non-traumatic cardiac arrest, whatever the initial rhythm. This simplification should enable more patients to be included in the procedure.
The aim of the study is to assess the patient's outcome
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- ECPR for out-of-hospital cardiac arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECPR for out-of-hospital cardiac arrestOther
Patient with out-of-hospital cardiac arrest enrolled in the ECPR protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival rate of patients enrolled in the protocol
Measured: 90 days after cardiac arrest
Secondary outcomes (2)
Delays
Delay between cardiac arrest and ECPR implementation
Measured: From event to implementation of ECMO, in minutes, Up to 180 minutes
Neurological outcome
Evaluation of neurological outcome of survivors after cardiac arrest using the Rankin score
Measured: 30 days and 90 days after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAEGER Deborah, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603649
- Sponsor's protocol ID
- 2024PI049
- Acronym
- ACEP-V2
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Updated Procedure for the Management of Refractory Out-of-hospital Cardiac Arrests with SAMU 54 : the Revised ACEP Protocol in 02/2024
- ClinicalTrials.gov ID
- NCT06603649
- Acronym / sponsor ID
- ACEP-V2 / 2024PI049
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. This led to an over-selection of patients and a significant reduction in the number of eligible patients. A balance needed to be struck between over-selecting patients and maintaining the expertise of medical and paramedical teams in the field. In addition, it has also been shown that ECPR also increases the number of organs and transplants.
In February 2024, the criteria for inclusion in the protocol were redefined to include any witnessed non-traumatic cardiac arrest, whatever the initial rhythm. This simplification should enable more patients to be included in the procedure.
The aim of the study is to assess the patient's outcome
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with refractory out-of-hospital cardiac arrest and enrolled in the ECPR program in Nancy, France. Inclusion criteria for the ECPR program are the following: * Age: 18-65 years * No major comorbidity * Witnessed non traumatic cardiac arrest * Low-flow to ECPR estimated of less than 60 minutes
Key inclusion criteria (4 listed)
- Out-of-hospital cardiac arrest
- enrolled in the ECPR program
- 18 years old or more
- Low-flow estimated <60minutes
Key exclusion criteria (2 listed)
- traumatic cardiac arrest
- major comorbidities
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 |
|---|---|---|
| ECPR for out-of-hospital cardiac arrestPatient with out-of-hospital cardiac arrest enrolled in the ECPR protocol | Other | – |
Primary outcome
Survival
Time frame: 90 days after cardiac arrest
Survival rate of patients enrolled in the protocol
2 secondary outcomes
Delays
Time frame: From event to implementation of ECMO, in minutes, Up to 180 minutes
Neurological outcome
Time frame: 30 days and 90 days after cardiac arrest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest, Out-Of-Hospital
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 90 days after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.