Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests (ACEP-V2)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Arrest, Out-Of-Hospital
• Intervention / Treatment: Other: ECPR for out-of-hospital cardiac arrest

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • CHRU
    • Contact: Deborah Jaeger, MD, PhD; Email: d.jaeger@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival rate of patients enrolled in the protocol	90 days after cardiac arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delays	Delay between cardiac arrest and ECPR implementation	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	30 days and 90 days after cardiac arrest

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2024PI049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No