CClinicalTrials.gg
Not yet recruitingNCT06603649ACEP-V2Updated Sep 19, 2024

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

An observational study in Cardiac Arrest, Out-Of-Hospital, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cardiac Arrest, Out-Of-Hospital
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • traumatic cardiac arrest
  • major comorbidities
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • OtherECPR for out-of-hospital cardiac arrest

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

06

What researchers measure

Primary outcomes

  1. Survival

    Survival rate of patients enrolled in the protocol

    Time frame: 90 days after cardiac arrest

Secondary outcomes

  1. Delays

    Delay between cardiac arrest and ECPR implementation

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

  2. Neurological outcome

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

    Time frame: 30 days and 90 days after cardiac arrest

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06603649
Lead sponsor
Central Hospital, Nancy, France
Responsible party
JAEGER Deborah (Principal investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Sep 1, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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