VIGAB-BIOSTAT: Neuronal Injury Panel Substudy

Withdrawn

• Conditions: Cardiac Arrest With Successful Resuscitation; Status Epilepticus
• Interventions: Diagnostic Test: Neuronal Injury Panel

• Registration Number: NCT05000320
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Post anoxic status epilepticus (PASE) is the development of intractable seizures in the post-cardiac arrest period once return of spontaneous circulation (ROSC) has been achieved. Historically, this condition has resulted in nearly 100% mortality, and the subset of patients diagnosed with PASE has been excluded from previous therapeutic trials in status epilepticus. The administration of vigabatrin, a GABA-ergic medication that blocks GABA catabolism, is being investigated as an adjunctive therapy to improve neurologic outcomes in this patient population through the VIGAB-STAT program at the University of Florida.

Neuroprognostication in cardiac arrest patients remains imprecise. Outcomes following cardiac arrest depend on a multitude of factors, from details of cardiac arrest (e.g., downtime and rhythm on arrest) to other factors that influence secondary brain injury-all of which are hard to ascertain from objective clinical and laboratory data. Neuronal and astroglial protein assays have been investigated in this patient population as a novel method of quantifying the degree of neuronal injury and may serve as an objective informant of ongoing secondary brain injury, thus being a helpful neuroprognostic tool. This assay can also demonstrate objectively if a neuroprotectant therapy mitigates secondary brain injury and decreases the overall hypoxic-brain injury burden. However, normative data on these assays on post-cardiac arrest patients suffering PASE are lacking.

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Status Verified: 2022-09
• Study Start: 2023-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-08-17
• Study Completion: 2024-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vigabatrin-naive	Neuronal Injury Panel	Adults 18 - 80 years of age suffering from post anoxic status epilepticus (PASE) who have not received vigabatrin.

Primary Outcome Measures

Name	Time	Method
Measure the degree of brain injury	Days 1 - 5	A neuronal Injury panel of assays will be conducted that may be used to measure the degree of brain injury