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

NCT06549426 | Recruiting DMC

• 1 other identifier: 2024-516068-27-01
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after cardiac arrest

Secondary Outcomes (1)

• quality adjusted life years (QALYs)

  12 months after cardiac arrest

Other Outcomes (5)

• survival in months

  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

  12 months after cardiac arrest

• score on the Rankin Scale (mRS)

  6 and 12 months after cardiac arrest

Study Arms (2)

Intervention group

OTHER

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)

Control group

NO INTERVENTION

Standard care without anti-seizure treatment.

Interventions

anti-seizure medication + sedative agent(s) DRUG

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)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 circulation (ROSC)
• ESE or possible ESE according to the Salzburg and ACNS criteria
• Possibility to start treatment within three hours after detection of ESE

You may not qualify 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

Sponsors & Collaborators

• University of Twente: lead
• Erasme University Hospital: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Belgium Health Care Knowledge Centre: collaborator

Study Sites (20)

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

NOT YET RECRUITING

Hôpital Universitaire de Bruxelles

Brussels, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire Marie Curie

Charleroi, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg

Genk, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Gent

Ghent, Belgium

NOT YET RECRUITING

Centre Hospitalier Chrétien - MontLégia

Liège, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire Sart-Tilmant

Liège, Belgium

NOT YET RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Netherlands

NOT YET RECRUITING

Medical Spectrum Twente

Enschede, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

NOT YET RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, Netherlands

NOT YET RECRUITING

VieCuri Medical Center

Venlo, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Coma; Status Epilepticus

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Seizures

Study Officials

• Jeannette Hofmeijer, MD

  University of Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeannette Hofmeijer, MD

CONTACT

+31 53 489 4835; j.hofmeijer@utwente.nl

Nicolas Gaspard, MD

CONTACT

+32 2 555 46 22; nicolas.gaspard@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 12, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (12); BE (8)