Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)
NCT Number: NCT06549426
Acronym: TELSTAR-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coma|Electrographic Status Epilepticus
Interventions: DRUG: anti-seizure medication + sedative agent(s)
Sponsor: University of Twente
Collaborators: Hôpital Universitaire de Bruxelles|ZonMw: The Netherlands Organisation for Health Research and Development|Belgium Health Care Knowledge Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2030-12
Locations: 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, Gent, Belgium|Centre Hospitalier Chrétien - MontLégia, Liège, Belgium|Centre Hospitalier Universitaire Sart-Tilmant, Liège, Belgium|Amsterdam University Medical Center, Amsterdam, Netherlands|Rijnstate Hospital, Arnhem, Netherlands|Catharina Hospital, Eindhoven, Netherlands|Medical Spectrum Twente, Enschede, Netherlands|University Medical Center Groningen, Groningen, Netherlands|Leiden University Medical Center, Leiden, Netherlands|St. Antonius Hospital, Nieuwegein, Netherlands|Canisius Wilhelmina Hospital, Nijmegen, Netherlands|Radboud University Medical Center, Nijmegen, Netherlands|Erasmus University Medical Center, Rotterdam, Netherlands|Maasstad Hospital, Rotterdam, Netherlands|VieCuri Medical Center, Venlo, Netherlands

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.

Primary Outcome Measures: score on the extended Glasgow Outcome Scale (eGOS), eGOS is an 8-points ordinal scale of functional recovery with possible scores ranging from 0 to 6. A higher score indicates better functional recovery, 6 months after cardiac arrest
Secondary Outcome Measures: quality adjusted life years (QALYs), this is a measure of cost-effectiveness, 12 months after cardiac arrest
Other Outcome Measures: survival in months, this is a measure of survival, 12 months after cardiac arrest|death (any cause), pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest, or thrombopenia, these are safety outcomes, 12 months after cardiac arrest|score on the Rankin Scale (mRS), mRS is a 6-point ordinal functional recovery scale with possible scores ranging from 1 to 6. A lower score indicates better functional recovery., 6 and 12 months after cardiac arrest|score on the cerebral performance categories (CPC), COC is a 5-point ordinal functional recovery scale with possible scores ranging from 1 to 5. A lower score indicates better functional recovery., 6 and 12 months after cardiac arrest|score on Montreal Cognitive Assessment telephone version, MoCA is a screening instrument to quantify overall cognitive functioning. Scores range from 0 to 30 with higher scores indicating better cognitive functioning., 6 months after cardiac arrest