NCT05000320

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2024

Completed
Last Updated

January 5, 2024

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

August 10, 2021

Last Update Submit

January 2, 2024

Conditions

Status EpilepticusCardiac Arrest With Successful Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Measure the degree of brain injury

    A neuronal Injury panel of assays will be conducted that may be used to measure the degree of brain injury

    Days 1 - 5

Study Arms (1)

Vigabatrin-naive

Adults 18 - 80 years of age suffering from post anoxic status epilepticus (PASE) who have not received vigabatrin.

Diagnostic Test: Neuronal Injury Panel

Interventions

Neuronal Injury PanelDIAGNOSTIC_TEST

A panel of neuronal and astroglial assays that may be a marker of brain injury.

Vigabatrin-naive

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 18-80 years of age suffering from post anoxic status epilepticus (PASE)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects must not have a prior history of generalized epilepsy
  • Be pregnant or
  • Have PASE onset preceding initiation of EEG monitoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Legriel S, Hilly-Ginoux J, Resche-Rigon M, Merceron S, Pinoteau J, Henry-Lagarrigue M, Bruneel F, Nguyen A, Guezennec P, Troche G, Richard O, Pico F, Bedos JP. Prognostic value of electrographic postanoxic status epilepticus in comatose cardiac-arrest survivors in the therapeutic hypothermia era. Resuscitation. 2013 Mar;84(3):343-50. doi: 10.1016/j.resuscitation.2012.11.001. Epub 2012 Nov 9.

    PMID: 23146879BACKGROUND

  • Backman S, Westhall E, Dragancea I, Friberg H, Rundgren M, Ullen S, Cronberg T. Electroencephalographic characteristics of status epilepticus after cardiac arrest. Clin Neurophysiol. 2017 Apr;128(4):681-688. doi: 10.1016/j.clinph.2017.01.002. Epub 2017 Jan 21.

    PMID: 28169132BACKGROUND

  • Huesgen KW, Elmelige YO, Yang Z, Chowdhury MAB, Gul S, Maciel CB, Elie-Turenne MC, Becker TK, Cohen SA, Holland A, Montero C, Zhu T, Wang KK, Tyndall JA; Florida Cardiac Arrest Resource Team. Ultra-early serum concentrations of neuronal and astroglial biomarkers predict poor neurological outcome after out-of-hospital cardiac arrest-a pilot neuroprognostic study. Resusc Plus. 2021 Jun 8;7:100133. doi: 10.1016/j.resplu.2021.100133. eCollection 2021 Sep.

    PMID: 34223394BACKGROUND

  • Wang KK, Yang Z, Zhu T, Shi Y, Rubenstein R, Tyndall JA, Manley GT. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018 Feb;18(2):165-180. doi: 10.1080/14737159.2018.1428089. Epub 2018 Jan 23.

    PMID: 29338452BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carolina Maciel, MD, MSCR

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 11, 2021

Study Start

January 1, 2023

Primary Completion

August 17, 2024

Study Completion

August 17, 2024

Last Updated

January 5, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share