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

Recruiting now · Not applicable

Conditions studied: Coma, Electrographic Status Epilepticus

In brief

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.

Key facts

Study ID

NCT06549426

Run by

University of Twente

People needed

150

Starts

2025-04-10

Expected to finish

2030-12-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Coma (Glasgow Coma Scale score ≤ 8) after out of hospital cardiac arrest and resuscitation
• Age ≥ 18 years
• Continuous EEG with at least eight electrodes started < 24h after return of spontaneous circulation (ROSC)
• ESE or possible ESE according to the Salzburg and ACNS criteria
• Possibility to start treatment within three hours after detection of ESE

You may not qualify if…

• Known history of another medical condition with limited life expectancy (< six months)
• Any progressive brain illness, such as a brain tumor or neurodegenerative disease
• Pre-admission Glasgow Outcome Scale score of 3 or lower
• Reason other than the neurological condition to withdraw treatment
• EEG background activity prior to the emergence of ESE indicative of extensive irreversible anoxic brain injury
• Follow-up impossible due to logistic reasons, for example not living in the Netherlands or Belgium

Where it is running

• VieCuri Medical Center — Venlo, Netherlands (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• Centre Hospitalier Universitaire Marie Curie — Charleroi, Belgium (enrolling)
• Centre Hospitalier Chrétien - MontLégia — Liège, Belgium (enrolling)
• Centre Hospitalier Universitaire Sart-Tilmant — Liège, Belgium (enrolling)
• Centre Hospitalier Universitaire Tivoli — Louvière, Belgium (enrolling)
• Centre Hospitalier Universitaire Saint-Pierre — Ottignies, Belgium (enrolling)
• Amsterdam University Medical Center — Amsterdam, Netherlands (enrolling)
• Rijnstate Hospital — Arnhem, Netherlands (enrolling)
• Radboud University Medical Center — Nijmegen, Netherlands (enrolling)
• Erasmus University Medical Center — Rotterdam, Netherlands (enrolling)
• Maasstad Hospital — Rotterdam, Netherlands (enrolling)
• Hôpital Universitaire de Bruxelles — Brussels, Belgium (enrolling)
• Catharina Hospital — Eindhoven, Netherlands (enrolling)
• Medical Spectrum Twente — Enschede, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• St. Antonius Hospital — Nieuwegein, Netherlands (enrolling)
• Amphia Ziekenhuis — Breda, Netherlands
• Leiden University Medical Center — Leiden, Netherlands
• Haga Ziekenhuis — The Hague, Netherlands
• Canisius Wilhelmina Hospital — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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