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Treatment of ELectroencephalographic STatus epilepticus After cardiopulmonary Resuscitation-2 (TELSTAR-2): a multicenter randomised clinical trial and health economic evaluation of anti-seizure treatment in comatose cardiac arrest patients with status epilepticus on continuous EEG.
EU CTIS ID: 2024-516068-27-01
What this study is testing
To determine if seizure suppression by stepwise anti-seizure treatment improves outcome of comatose patients after cardiac arrest with ESE, as compared with no anti-seizure treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 cir-culation (ROSC)
- ESE or possible ESE according to the Salzburg and ACNS criteria
- Possibility to start treatment within three hours after detection of ESE
You likely can't join if
- 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
See the full eligibility criteria
- 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 cir-culation (ROSC)
- ESE or possible ESE according to the Salzburg and ACNS criteria
- Possibility to start treatment within three hours after detection of ESE
- 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
- Insufficient understanding of the Dutch or French language.
- Known hypersensitivity to the anti-seizure medication recommended for the intervention group (of note, in case of hypersensitivity to one or two of the recommended medications, the patient can be included, provided that medications at stake will not be used)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.