Status EpilepticusNCT05000320
VIGAB-BIOSTAT: Neuronal Injury Panel Substudy
An observational study of Status Epilepticus and Cardiac Arrest With Successful Resuscitation, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Status Epilepticus, Cardiac Arrest With Successful Resuscitation
- What is being tested?
- Neuronal Injury Panel
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 17 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18-80 years of age suffering from post anoxic status epilepticus (PASE)
Who may be able to join
- 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.
Who cannot join
- Subjects must not have a prior history of generalized epilepsy
- Be pregnant or
- Have PASE onset preceding initiation of EEG monitoring.
About this study
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.
Read the 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.
- Being tested
- Neuronal Injury Panel
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronal Injury PanelDiagnostic test
A panel of neuronal and astroglial assays that may be a marker of brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Vigabatrin-naive | Adults 18 - 80 years of age suffering from post anoxic status epilepticus (PASE) who have not received vigabatrin. Receives: Diagnostic Test: Neuronal Injury Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1 - 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study startJan 2023 (estimated)
- Primary completion17 Aug 2024 (estimated)
- Study completion17 Aug 2024 (estimated)
Why it stopped: study never open to accrual and no subjects were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Maciel, MD, MSCR, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000320
- Sponsor's protocol ID
- VIGAB-BIOSTAT
- Other IDs
- IRB202101781, OCR41006
- Status last verified
- Sep 2022
- First submitted
- 10 Aug 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23146879Backman 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.
PubMed 28169132Huesgen 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.
PubMed 34223394Wang 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.
PubMed 29338452
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIGAB-BIOSTAT: Neuronal Injury Panel Substudy
- ClinicalTrials.gov ID
- NCT05000320
- Acronym / sponsor ID
- VIGAB-BIOSTAT
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study never open to accrual and no subjects were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vigabatrin-naive | – | Diagnostic Test: Neuronal Injury PanelAdults 18 - 80 years of age suffering from post anoxic status epilepticus (PASE) who have not received vigabatrin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18-80 years of age suffering from post anoxic status epilepticus (PASE)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects must not have a prior history of generalized epilepsy
- Be pregnant or
- Have PASE onset preceding initiation of EEG monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuronal Injury PanelA panel of neuronal and astroglial assays that may be a marker of brain injury. | Diagnostic test | Vigabatrin-naive |
Primary outcome
Measure the degree of brain injury
Time frame: Days 1 - 5
A neuronal Injury panel of assays will be conducted that may be used to measure the degree of brain injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 23146879Legriel 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.
- Background: PubMed 28169132Backman 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.
- Background: PubMed 34223394Huesgen 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.
- Background: PubMed 29338452Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Maciel, MD, MSCR principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus and Cardiac Arrest With Successful Resuscitation, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the degree of brain injury (time frame: Days 1 - 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000320, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 29 Oct 2026.