An interventional study of anti-seizure medication + sedative agent(s) in Coma and Electrographic Status Epilepticus, sponsored by University of Twente. Recruiting at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of Twente · Not applicable, Interventional, and Treatment
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:
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.
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 from severe brain injury. EEG is used as a predictor of outcome, helping decide whether life sustaining therapies should be pursued or withdrawn. EEG shows epileptiform patterns meeting criteria for electrographic status epilepticus (ESE) in up to 10% of patients, with 80-100% case fatality. With the TELSTAR-1 trial, we showed that anti-seizure treatment of unselected patients with epileptiform patterns is not associated with a better outcome. However, it remains unclear whether treatment of (possible) ESE will improve outcome, or if ESE simply represents irreversible severe brain damage, in which case such treatment will be futile. This translates into ongoing practice variation. To provide comatose cardiac arrest survivors with the best medical treatment options, while at the same time preventing unnecessary costly ICU treatment, unequivocal evidence of efficacy or futility of ESE treatment is needed.
Objectives: It is the primary objective to study whether ESE treatment improves outcome of comatose patients after cardiac arrest. It is the secondary objective to study the impact on healthcare costs of ESE treatment.
Main trial endpoints: The primary outcome measure will be functional recovery expressed as the score on the extended Glasgow Outcome Scale (eGOS) at six months after cardiac arrest. The primary effect parameter will be the common odds ratio for any shift towards a better outcome in the intervention group, analyzed by multivariable ordinal logistic regression.
Secondary trial endpoints: Secondary outcome measures include data on quality of life, cognitive functioning, and the use of resources. Cost-effectiveness will be assessed, separately for Belgium and for the Netherlands, adhering to 'KCE' and 'Zorginstituut' guidelines for pharmaco-economic evaluations, respectively.
Trial design: This will be a comparative effectiveness study, comparing two standard treatment regimens. We will conduct a prospective multicentre trial with randomized treatment allocation, open label treatment, and blinded endpoint assessment on twenty intensive care units in the Netherlands and Belgium.
Trial population: The study population consists of adult comatose patients after out of hospital cardiac arrest and successful cardiopulmonary resuscitation, admitted on the intensive care unit of any of the participating centres, with ESE on continuous EEG. Continuous EEG is part of standard care in all participating hospitals. For the definition of ESE, we adhere to international consensus criteria.
Interventions: Treatment in the intervention group will consist of standard care completed with anti-seizure treatment according to protocols for clinically overt status epilepticus with the goal of definitive seizure suppression. This consists of a stepwise approach, step 1 being a single dose of a parenteral benzodiazepine (lorazepam, midazolam, or diazepam) and a first parenteral anti-seizure medication (levetiracetam, valproate, or lacosamide), step 2, a second parenteral anti-seizure medication plus a first continuous parenteral sedative agent (midazolam or propofol), and step 3, a second continuous parenteral sedative agent (midazolam, propofol, or ketamine). Each next step will be taken as soon as possible (within 30 minutes) if the previous step was insufficiently effective to suppress ESE. The control group will receive standard care without anti-seizure treatment.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 150 is above the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →University of Twente is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care completed with stepwise anti-seizure treatment according to protocols for clinically overt status epilepticus. This consists of a stepwise approach consisting of 3 potential steps. Each next step will be taken as soon as possible (within 30 minutes of ESE first diagnosis or recurrence) if the previous step was insufficiently effective to sustainably suppress ESE.
Drug: anti-seizure medication + sedative agent(s)
Standard care without anti-seizure treatment.
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)
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
Time frame: 6 months after cardiac arrest
quality adjusted life years (QALYs)
this is a measure of cost-effectiveness
Time frame: 12 months after cardiac arrest
survival in months
this is a measure of survival
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after cardiac arrest
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Started Apr 2025 (actual). Primary completion is estimated for Dec 2029, 56 months after the start.
Of 39 non-industry interventional studies with no phase under Coma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's planned 56 months is above that.
Counting every sponsor, half of 39 studies reached it within 39 months; a quarter within 17 and three quarters within 54.
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University of Twente