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Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)

NCT06549426 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Coma
  • Electrographic Status Epilepticus

Interventions

DRUG

anti-seizure medication + sedative agent(s)

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)

Sponsors & Collaborators

  • Hôpital Universitaire de Bruxelles

    collaborator UNKNOWN

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Belgium Health Care Knowledge Centre

    collaborator OTHER_GOV

  • University of Twente

    lead OTHER

Principal Investigators

  • Jeannette Hofmeijer, MD · University of Twente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549426 on ClinicalTrials.gov