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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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516068-27-01
Enrollment
150
Registered
2025-03-25
Start date
2025-04-10
Completion date
Unknown
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiopulmonary resuscitation, comatose, status epilepticus, cardiac arrest

Brief summary

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. eGOS scores at six months are obtained by a standardized telephone interview conducted by an independent investigator, who is masked to treatment allocation and EEG pattern.

Detailed description

Cost-effectiveness analysis outcomes are Quality Adjusted Life Years (QALYs), costs, Incremental Cost Effectiveness Ratio (ICER), incremental cost-effectiveness plane, and incremental cost-effectiveness acceptability curve.

Interventions

DRUGPropofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
DRUGDiazepam CF 5 mg/ml
DRUGoplossing voor injectie
DRUGLorazepam Macure 4 mg/ml oplossing voor injectie
DRUGDepakine i.v. 400
DRUGpoeder voor injectievloeistof 400 mg
DRUGVimpat 10 mg/ml solution for infusion
DRUGMidazolam Eugia 1 mg/ml

Sponsors

Universiteit Twente
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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. eGOS scores at six months are obtained by a standardized telephone interview conducted by an independent investigator, who is masked to treatment allocation and EEG pattern.

Secondary

MeasureTime frame
Cost-effectiveness analysis outcomes are Quality Adjusted Life Years (QALYs), costs, Incremental Cost Effectiveness Ratio (ICER), incremental cost-effectiveness plane, and incremental cost-effectiveness acceptability curve.

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026