An observational study in Cardiac Arrest (CA), Intensive Care Unit (ICU) Admission and Return of Spontaneous Circulation, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
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Comatose patients after cardiac arrest
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Exclusion Criteria:
Patients
Other: Value of neurofilament light chain (NFL) at different time points
Value of neurofilament light chain (NFL) at different time points (H0, H12, H24, H48, H72, H96, and day 7 after ICU admission
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
Mortality
Time frame: At ICU discharge, up to 3 months
Early myoclonus
Clinical, imaging, or neurophysiological neurological abnormalities : early myoclonus (\<72 hours)
Time frame: <72 hours
Myoclonus status
Clinical, imaging, or neurophysiological neurological abnormalities: myoclonus status (\<72 hours post-CA)
Time frame: <72 hours post-CA
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
Pupillary and corneal reflexes
Clinical, imaging, or neurophysiological neurological abnormalities: brain imaging, if performed
Time frame: 3 months
Electroencephalogram (EEG)
Neurological abnormalities
Time frame: 3 months
Somatosensory evoked potentials
Neurological abnormalities
Time frame: 3 months
Auditory evoked potentials
Neurological abnormalities
Time frame: 3 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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