RecruitingN/AOther

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

Sponsored by University of Twente

NCT ID
NCT06549426
Target Enrollment
150 participants
Start Date
2025-04-10
Est. Completion
2030-12

About This Study

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.

Conditions Studied

ComaElectrographic Status Epilepticus

Interventions

  • anti-seizure medication + sedative agent(s)

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations (20)

Centre Hospitalier Universitaire Saint-Pierre
Brussels, Belgium
Hôpital Universitaire de Bruxelles
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Centre Hospitalier Universitaire Marie Curie
Charleroi, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre Hospitalier Chrétien - MontLégia
Liège, Belgium
Centre Hospitalier Universitaire Sart-Tilmant
Liège, Belgium
Amsterdam University Medical Center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands

+10 more locations

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Jeannette Hofmeijer, MD
CONTACT
+31 53 489 4835j.hofmeijer@utwente.nl
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source