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NCT Number: NCT06603649

Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests

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

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Key information

Conditions

Cardiac Arrest, Out-Of-Hospital Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Out-of-hospital cardiac arrest
  • enrolled in the ECPR program
  • 18 years old or more
  • Low-flow estimated <60minutes

Exclusion criteria

  • traumatic cardiac arrest
  • major comorbidities

Treatment and study plan

ECPR for out-of-hospital cardiac arrest

Other

Patient with out-of-hospital cardiac arrest enrolled in the ECPR protocol

Primary outcomes

  1. Survival

    Time frame: 90 days after cardiac arrest

    Survival rate of patients enrolled in the protocol

Secondary outcomes

  1. Delays

    Time frame: From event to implementation of ECMO, in minutes, Up to 180 minutes

    Delay between cardiac arrest and ECPR implementation

  2. Neurological outcome

    Time frame: 30 days and 90 days after cardiac arrest

    Evaluation of neurological outcome of survivors after cardiac arrest using the Rankin score

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: ACEP-V2

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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