WithdrawnNot Applicable

VIGAB-BIOSTAT: Neuronal Injury Panel Substudy

Stopped: study never open to accrual and no subjects were enrolled

0Started 2023-01

Plain-language summary

The purpose of this substudy is to collect and analyze control data to characterize the degree of neuronal injury in PASE patients who have not received vigabatrin to later compare with patients who received this therapy and expand data on the utility of the neuronal injury panel for neuroprognostication. Data from this cohort will be compared with the data generated by the treatment cohort in the main VIGAB-STAT study.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * To be included in the study, subjects must be 18 - 80 years of age * Non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic SE (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching \> 4Hz, lasting ≥ 10 minutes, or comprising \> 50% of any hour of recording) has been made, * Requiring anesthetic infusion for any reason, * Have reliable arterial access for frequent blood sampling * Be enrolled and have the first specimen drawn within 48 hours of PASE onset. Exclusion Criteria: * Subjects must not have a prior history of generalized epilepsy * Be pregnant or * Have PASE onset preceding initiation of EEG monitoring.

What they're measuring

Measure the degree of brain injury

Timeframe: Days 1 - 5

Trial details

NCT IDNCT05000320

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-17

View on ClinicalTrials.gov More Status Epilepticus trials