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

NCT06603649 | Not Yet Recruiting

• 1 other identifier: 2024PI049
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival rate of patients enrolled in the protocol

  90 days after cardiac arrest

Secondary Outcomes (2)

• Delays

  From event to implementation of ECMO, in minutes, Up to 180 minutes

• Neurological outcome

  30 days and 90 days after cardiac arrest

Interventions

ECPR for out-of-hospital cardiac arrest OTHER

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• traumatic cardiac arrest
• major comorbidities

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU

Nancy, France

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

FR (1)