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

Not yet recruiting

• Conditions: Cardiac Arrest, Out-Of-Hospital

• Registration Number: NCT06603649
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2030-09-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	90 days after cardiac arrest	Survival rate of patients enrolled in the protocol

Secondary Outcome Measures

Name	Time	Method
Delays	From event to implementation of ECMO, in minutes, Up to 180 minutes	Delay between cardiac arrest and ECPR implementation
Neurological outcome	30 days and 90 days after cardiac arrest	Evaluation of neurological outcome of survivors after cardiac arrest using the Rankin score

Trial Locations

Locations (1)

CHRU; 🇫🇷 Nancy, France