Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06549426

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

Led by University of Twente · Updated on 2025-05-16

150

Participants Needed

20

Research Sites

294 weeks

Total Duration

On this page

Sponsors

U

University of Twente

Lead Sponsor

E

Erasme University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Coma (Glasgow Coma Scale score 64 8) after out of hospital cardiac arrest and resuscitation
  • Age 65 18 years
  • Continuous EEG with at least eight electrodes started < 24h after return of spontaneous circulation (ROSC)
  • Electrographic status epilepticus (ESE) or possible ESE according to Salzburg and ACNS criteria
  • Possibility to start treatment within three hours after detection of ESE
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

Not Yet Recruiting

2

Hôpital Universitaire de Bruxelles

Brussels, Belgium

Not Yet Recruiting

3

Universitair Ziekenhuis Brussel

Brussels, Belgium

Not Yet Recruiting

4

Centre Hospitalier Universitaire Marie Curie

Charleroi, Belgium

Not Yet Recruiting

5

Ziekenhuis Oost-Limburg

Genk, Belgium

Not Yet Recruiting

6

Universitair Ziekenhuis Gent

Ghent, Belgium

Not Yet Recruiting

7

Centre Hospitalier Chrétien - MontLégia

Liège, Belgium

Not Yet Recruiting

8

Centre Hospitalier Universitaire Sart-Tilmant

Liège, Belgium

Not Yet Recruiting

9

Amsterdam University Medical Center

Amsterdam, Netherlands

Not Yet Recruiting

10

Rijnstate Hospital

Arnhem, Netherlands

Actively Recruiting

11

Catharina Hospital

Eindhoven, Netherlands

Not Yet Recruiting

12

Medical Spectrum Twente

Enschede, Netherlands

Actively Recruiting

13

University Medical Center Groningen

Groningen, Netherlands

Not Yet Recruiting

14

Leiden University Medical Center

Leiden, Netherlands

Not Yet Recruiting

15

St. Antonius Hospital

Nieuwegein, Netherlands

Actively Recruiting

16

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Not Yet Recruiting

17

Radboud University Medical Center

Nijmegen, Netherlands

Actively Recruiting

18

Erasmus University Medical Center

Rotterdam, Netherlands

Actively Recruiting

19

Maasstad Hospital

Rotterdam, Netherlands

Not Yet Recruiting

20

VieCuri Medical Center

Venlo, Netherlands

Not Yet Recruiting

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Research Team

J

Jeannette Hofmeijer, MD

CONTACT

N

Nicolas Gaspard, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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