Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Twente
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- anti-seizure medication + sedative agent(s)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Twente
Lead sponsor
Erasme University Hospital
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Belgium Health Care Knowledge Centre
Collaborator
Source ClinicalTrials.gov