Out-of-Hospital Cardiac ArrestReCATOBENCT06397417
Refractory Cardiac Arrest Treated On Field By ECMO
An observational study of Out-of-Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
- What is being tested?
- Data collection
- How many people
- 840 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2025to Mar 2046
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have benefited from an installation or attempted installation of an extracorporeal membrane oxygenation (ECMO) device following a non-traumatic refractory cardiac arrest as part of the ECMO TEAM of the Samu de Paris during the time of the study.
Who may be able to join
- All patients who have benefited from an installation or attempted installation of an extracorporeal membrane oxygenation (ECMO) device following a non-traumatic refractory cardiac arrest as part of the ECMO TEAM of the Samu de Paris during the time of the study.
- Obtaining non-opposition from the patient or a relative in the event of the patient's death or a lasting state of health preventing them from becoming aware of the study.
Who cannot join
- Minor patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Jean-Herlé Raphalen, MD, 1 71 19 63 46 ext. +33, jena-herle.raphalen@aphp.fr
Damien VIMPERE, MD
About this study
Official title: Prognosis of Refractory Out-of-hospital Cardiac Arrests Treated With Extracorporeal Cardiopulmonary Resuscitation (ECMO) by the Urgent Medical Aid Service (SAMU) of Paris
Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.
Read the detailed description
Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.
The study consists of establishing a prospective register over a period of 20 years of patients aged over 18 years, victims of refractory non-traumatic out-of-hospital cardiac arrest in the coverage area of the ECMO TEAM of the Paris SAMU.
The 1-year survival rate of patients will be measured, the functional prognosis will be evaluated and a search for associated factors will be carried out. Patients' long-term cardiac function will be collected as well as the incidence of ECPR-related complications.
- Being tested
- Data collection
- Keywords
- Out-of-Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
- 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.
Data collectionOther
The data from hospital treatment will be used for research as well as subsequently, that is to say after discharge from the intensive care units, medical reports and correspondence with the attending physician will be used for the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients | All patients over 18 years of age who will benefit from an installation or an attempt at an ECMO installation following a non-traumatic refractory cardiac arrest care by the ECMO TEAM of the Paris SAMU over a period of 20 years old. Patients' medical data will be collected for one year after their care. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival rate at 1 year after an extracorporeal cardiopulmonary resuscitation by the ECMO TEAM of the Paris SAMU.
Measured: 1 year
Secondary outcomes (5)
Neurological prognosis
Evaluation of the functional prognosis at 1 year by the score at the Cerebral Performance Category Scale. A favorable outcome is defined by a score of 1 or 2. The score on the brain performance category scale will be determined based on hospital records and/or telephone interview with the general practitioner. The CPC score: [5: death, 4: persistent vegetative state, 3: severe disability, 2: moderate disability, 1: low disability].
Measured: 1 year
Quality of life assessment
Evaluation of the functional prognosis at 1 year by measure of the quality of life assessed by the Short Form (36) Health Survey (SF36). The SF-36 test is a standardized questionnaire for measuring quality of life. It is carried out during a follow-up medical consultation. Description of the overall SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perception, physical role functioning, emotional role functioning, social role functioning, mental health).
Measured: 1 year
Incidence of ECPR-related complications
Measurement of the incidence of complications linked to ECPR (extracorporeal cardiopulmonary resuscitation) : bleeding at the cannula puncture site, lower limb ischemia, post-load pulmonary edema, bacteremia, insertion site infection.
Measured: 1 year
Left ventricular ejection fraction (LVEF)
Assessment of long-term cardiac function based on the data from the imaging reports carried out by the downstream services and/or the telephone interview with the general practitioner or specialist doctor.
Measured: 1 year
Occurrence of major cardioavscular events
Report of occurrence of major cardioavscular events through analysis of medical reports within one year after cardiac arrest. Major cardioavscular events are defined as : recurrence of cardiac arrest, acute coronary syndrome, ventricular rythm disorders, acute heart failure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start5 Mar 2025
- Primary completionMar 2046 (estimated)
- Study completionMar 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Herlé Raphalen, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397417
- Sponsor's protocol ID
- APHP231680
- Acronym
- ReCATOBE
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Refractory Out-of-hospital Cardiac Arrests Treated With Extracorporeal Cardiopulmonary Resuscitation (ECMO) by the Urgent Medical Aid Service (SAMU) of Paris
- ClinicalTrials.gov ID
- NCT06397417
- Acronym / sponsor ID
- ReCATOBE / APHP231680
- Keywords
- Out-of-Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Mar 2046 (estimated)
- Study completion
- Mar 2046 (estimated)
- First posted
- 2 May 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.
Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.
Detailed description
Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.
The study consists of establishing a prospective register over a period of 20 years of patients aged over 18 years, victims of refractory non-traumatic out-of-hospital cardiac arrest in the coverage area of the ECMO TEAM of the Paris SAMU.
The 1-year survival rate of patients will be measured, the functional prognosis will be evaluated and a search for associated factors will be carried out. Patients' long-term cardiac function will be collected as well as the incidence of ECPR-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Data collectionAll patients over 18 years of age who will benefit from an installation or an attempt at an ECMO installation following a non-traumatic refractory cardiac arrest care by the ECMO TEAM of the Paris SAMU over a period of 20 years old. Patients' medical data will be collected for one year after their care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have benefited from an installation or attempted installation of an extracorporeal membrane oxygenation (ECMO) device following a non-traumatic refractory cardiac arrest as part of the ECMO TEAM of the Samu de Paris during the time of the study.
Key inclusion criteria (2 listed)
- All patients who have benefited from an installation or attempted installation of an extracorporeal membrane oxygenation (ECMO) device following a non-traumatic refractory cardiac arrest as part of the ECMO TEAM of the Samu de Paris during the time of the study.
- Obtaining non-opposition from the patient or a relative in the event of the patient's death or a lasting state of health preventing them from becoming aware of the study.
Key exclusion criteria (1 listed)
- Minor patients
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 |
|---|---|---|
| Data collectionThe data from hospital treatment will be used for research as well as subsequently, that is to say after discharge from the intensive care units, medical reports and correspondence with the attending physician will be used for the study. | Other | Patients |
Primary outcome
Survival
Time frame: 1 year
Survival rate at 1 year after an extracorporeal cardiopulmonary resuscitation by the ECMO TEAM of the Paris SAMU.
5 secondary outcomes
Neurological prognosis
Time frame: 1 year
Quality of life assessment
Time frame: 1 year
Incidence of ECPR-related complications
Time frame: 1 year
Left ventricular ejection fraction (LVEF)
Time frame: 1 year
Occurrence of major cardioavscular events
Time frame: 1 year
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 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Out-of-Hospital Cardiac Arrest
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
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
Jean-Herlé Raphalen, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Out-of-Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
Contact Jean-Herlé Raphalen, MD (1 87 89 29 63 ext. +33, jena-herle.raphalen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). 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 12 Sep 2025.