Status:
RECRUITING
Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)
Lead Sponsor:
University of Twente
Collaborating Sponsors:
Hôpital Universitaire de Bruxelles
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Coma
Electrographic Status Epilepticus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ar...
Detailed Description
Rationale: Around 7500 comatose patients after cardiac arrest and resuscitation are admitted to intensive care units (ICUs) in the Netherlands and Belgium, yearly. Approximately half eventually dies f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06549426
Start Date
April 10 2025
End Date
December 1 2030
Last Update
May 16 2025
Active Locations (20)
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1
Centre Hospitalier Universitaire Saint-Pierre
Brussels, Belgium
2
Hôpital Universitaire de Bruxelles
Brussels, Belgium
3
Universitair Ziekenhuis Brussel
Brussels, Belgium
4
Centre Hospitalier Universitaire Marie Curie
Charleroi, Belgium