Refractory Cardiac Arrest Treated On Field By ECMO

NCT06397417 | Recruiting

• 1 other identifier: APHP231680
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Out-of-Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation

Keywords

Out-of-Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival rate at 1 year after an extracorporeal cardiopulmonary resuscitation by the ECMO TEAM of the Paris SAMU.

  1 year

Secondary Outcomes (5)

• Neurological prognosis

  1 year

• Quality of life assessment

  1 year

• Incidence of ECPR-related complications

  1 year

• Left ventricular ejection fraction (LVEF)

  1 year

• Occurrence of major cardioavscular events

  1 year

Study Arms (1)

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.

Other: Data collection

Interventions

Data collection OTHER

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Minor patients

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-Herlé Raphalen, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Herlé Raphalen, MD

CONTACT

1 87 89 29 63; jena-herle.raphalen@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 2, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): March 1, 2046
• Study Completion (Estimated): March 1, 2046
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)