RecruitingNot ApplicableNCT06549426

Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)

Treatment of ELectrographic STatus Epilepticus After Cardiopulmonary Resuscitation-2: Multicenter Randomised Clinical Trial and Health Economic Evaluation of Anti-seizure Treatment in Comatose Cardiac Arrest Patients With SE on Continuous EEG


Sponsor

University of Twente

Enrollment

150 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this comparative effectiveness trial is to study electrographic status epilepticus (ESE) treatment in comatose patients after cardiac arrest. The main questions the trial aims to answer are: * Does ESE treatment improve outcome? * What is the impact of ESE treatment on healthcare costs? Participants in the the intervention group will receive standard care completed with anti-seizure treatment. The control group will receive standard care without anti-seizure treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called anti-seizure medication + sedative agent(s) for people with electrographic status epilepticus and coma. The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGanti-seizure medication + sedative agent(s)

Stepwise approach: 1. a single dose of a parenteral benzodiazepine (lorazepam, midazolam, or diazepam) and a first parenteral anti-seizure medication (levetiracetam, valproate, or lacosamide) 2. a second parenteral anti-seizure medication plus a first continuous parenteral sedative agent (midazolam or propofol) 3. a second continuous parenteral sedative agent (midazolam, propofol, or ketamine)


Locations(21)

Hôpital Universitaire de Bruxelles

Brussels, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Centre Hospitalier Universitaire Marie Curie

Charleroi, Belgium

Centre Hospitalier Chrétien - MontLégia

Liège, Belgium

Centre Hospitalier Universitaire Sart-Tilmant

Liège, Belgium

Centre Hospitalier Universitaire Tivoli

Louvière, Belgium

Centre Hospitalier Universitaire Saint-Pierre

Ottignies, Belgium

Amsterdam University Medical Center

Amsterdam, Netherlands

Rijnstate Hospital

Arnhem, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Catharina Hospital

Eindhoven, Netherlands

Medical Spectrum Twente

Enschede, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Maasstad Hospital

Rotterdam, Netherlands

Haga Ziekenhuis

The Hague, Netherlands

VieCuri Medical Center

Venlo, Netherlands

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NCT06549426


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