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

NCT07760636 | Not Yet Recruiting

• 2 other identifiers: APHP251892 - CINEFIL2025-A02758-41
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest (CA); Intensive Care Unit (ICU) Admission; Return of Spontaneous Circulation; Comatose

Keywords

Cardiac arrest; Coma; Neuroprognostication; Biomarkers; Neurofilament light chain

Outcome Measures

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))

  3 months

Secondary Outcomes (8)

• Mortality

  At ICU discharge, up to 3 months

• Early myoclonus

  <72 hours

• Myoclonus status

  <72 hours post-CA

• Pupillary and corneal reflexes

  72 hours post-CA

• Pupillary and corneal reflexes

  3 months

Study Arms (1)

Patients

Patients

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

Interventions

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

Patients

Eligibility Criteria

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

Study Population

Comatose patients after cardiac arrest

You may qualify if:

• 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,

You may not qualify if:

• 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,
• Restriction of active therapies prior to the first NFL biomarker assay,
• Objection by a family member or trusted person, if present

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Medical ICU

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Heart Arrest; Coma; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Benghanem

  Medical ICU, Cochin hospital, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Benghanem, MD PhD

CONTACT

+ 00 33 1 58 41 43 3; sarah.benghanem@aphp.fr

Marie Benhammani-Godard

CONTACT

0033158411190; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-07

Locations

FR (1)