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
University of Twente
150 participants
Apr 10, 2025
INTERVENTIONAL
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
Inclusion Criteria5
- 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 Criteria6
- 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
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Interventions
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(20)
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NCT06549426