RecruitingNot Applicable

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

Belgium150 participantsStarted 2025-04-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

score on the extended Glasgow Outcome Scale (eGOS)

Timeframe: 6 months after cardiac arrest

Trial details

NCT IDNCT06549426

SponsorUniversity of Twente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Jeannette Hofmeijer, MD

+31 53 489 4835 j.hofmeijer@utwente.nl

View on ClinicalTrials.gov More Coma trials