Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
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.
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:
NCT05000320
Study Brief:
Protocol Section:
NCT05000320