Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07760636

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

A large majority of patients resuscitated after cardiac arrest (CA) are comatose following the return of spontaneous circulation and require admission to the intensive care unit (ICU). Unfortunately, many of them die during their ICU stay, mainly following the decision to withdraw life-sustaining therapies due to ischemic and hypoxic brain injuries considered irreversible. Early identification of these neurological injury is therefore one of the major challenges for intensivists, in order to tailor the intensity of care.

Currently, the recommended strategy consists of applying a multimodal prognostic approach. This algorithm allows prediction of poor neurological outcome in approximately 50% of cases, according to various studies. This highlights the need for new early prognostic markers to predict both unfavorable and favorable outcomes.

Regarding biomarkers of brain injury, European guidelines recommend the measurement of serum NSE, a biomarker of neuronal injury that is now commonly used. An NSE level > 60 µg/L at 48 and/or 72 hours after cardiac arrest predicts poor neurological outcome with good accuracy (AUC between 0.80 and 0.92 depending on the study), high specificity but limited sensitivity. Moreover, uncertainty remains regarding the optimal threshold value to use, and variable results have been reported across clinical studies. Finally, early serum NSE levels (within the first 24-48 hours) have limited prognostic value, which restricts their usefulness for the early identification of patients likely to have a poor outcome. These limitations have highlighted the need to identify new biomarkers of brain injury to better assess the prognosis of these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • Terminally ill patients (death expected within 3 hours of admission to the ICU),
  • Minors,
  • Patients under legal guardianship,
  • Pregnant women,
  • Patients not enrolled in a social security program,
  • Prior inclusion in the CINEFIL study,
  • Restriction of active therapies prior to the first NFL biomarker assay,
  • Objection by a family member or trusted person, if present

Treatment and study plan

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

Other

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

Primary outcomes

  1. modified Rankin Scale (mRS)

    Time frame: 3 months

    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))

Secondary outcomes

  1. Mortality

    Time frame: At ICU discharge, up to 3 months

  2. Early myoclonus

    Time frame: <72 hours

    Clinical, imaging, or neurophysiological neurological abnormalities :

    early myoclonus (<72 hours)

  3. Myoclonus status

    Time frame: <72 hours post-CA

    Clinical, imaging, or neurophysiological neurological abnormalities:

    myoclonus status (<72 hours post-CA)

  4. Pupillary and corneal reflexes

    Time frame: 72 hours post-CA

    Clinical, imaging, or neurophysiological neurological abnormalities:

    pupillary and corneal reflexes at 72 hours post-CA

  5. Pupillary and corneal reflexes

    Time frame: 3 months

    Clinical, imaging, or neurophysiological neurological abnormalities:

    brain imaging, if performed

  6. Electroencephalogram (EEG)

    Time frame: 3 months

    Neurological abnormalities

  7. Somatosensory evoked potentials

    Time frame: 3 months

    Neurological abnormalities

  8. Auditory evoked potentials

    Time frame: 3 months

    Neurological abnormalities

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Benhammani-Godard

CONTACT

[email protected]

0033158411190

Sarah Benghanem, MD PhD

CONTACT

[email protected]

+ 00 33 1 58 41 43 3

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CINEFIL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.