Kinetics and Prognostic Value of NeuroFilament Light in Post-cardiac Arrest: A Prospective Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to assess the prognostic value of absolute value and kinetic of neurofilament light chain (NFL) collected at different time points (at admission, 12h, 24h, 48h, 72h, 96h, and day 7 after ICU admission) in predicting poor and good neurological outcome in comatose patients after cardiac arrest.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients admitted to the ICU for cardiac arrest,

Patients who regained consciousness following in-hospital or out-of-hospital cardiac arrest,

Patients in a coma upon arrival in the ICU, defined by a Glasgow Coma Scale (GCS) score <8,

Patients included in the AfterROSC2 cohort,

Disqualifiers

Terminally ill patients (death expected within 3 hours of admission to the ICU),

Minors,

Patients under legal guardianship,

Pregnant women,

Trial population

Comatose patients after cardiac arrest

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Value of neurofilament light chain (NFL) at different time points

    Other intervention

    Value of neurofilament light chain (NFL) at different time points (H0, H12, H24, H48, H72, H96, and day 7 after ICU admission

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

modified Rankin Scale (mRS)

Neurological outcome assessed by the modified Rankin Scale (mRS) (An unfavorable outcome is defined as a modified Rankin Scale (mRS) score between 4 and 6 (severe neurological sequelae, persistent coma, or death), and a favorable outcome as a modified Rankin Scale (mRS) score between 0 and 3 (no sequelae, mild to moderate neurological sequelae))

Time frame
3 months

Secondary outcomes

1

Mortality

Time frame
At ICU discharge, up to 3 months
2

Early myoclonus

Clinical, imaging, or neurophysiological neurological abnormalities : early myoclonus (\<72 hours)

Time frame
<72 hours
3

Myoclonus status

Clinical, imaging, or neurophysiological neurological abnormalities: myoclonus status (\<72 hours post-CA)

Time frame
<72 hours post-CA
4

Pupillary and corneal reflexes

Clinical, imaging, or neurophysiological neurological abnormalities: pupillary and corneal reflexes at 72 hours post-CA

Time frame
72 hours post-CA

Other outcomes

Sponsors and contacts

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