Treatment for brain activity issues after cardiac arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of anti-seizure treatment in comatose patients who have experienced cardiac arrest and show signs of electrographic status epilepticus (ESE). Participants will be divided into two groups: one receiving standard care with anti-seizure medication and the other receiving standard care without it. The study aims to determine if ESE treatment can improve patient outcomes and reduce healthcare costs. The primary outcome will be assessed using the extended Glasgow Outcome Scale six months after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Coma (Glasgow Coma Scale score ≤ 8) after out of hospital cardiac arrest and resuscitation
2. Age ≥ 18 years
3. Continuous EEG with at least eight electrodes started \< 24h after return of spontaneous circulation (ROSC)
4. ESE or possible ESE according to the Salzburg and ACNS criteria
5. Possibility to start treatment within three hours after detection of ESE

Exclusion Criteria:

1. Known history of another medical condition with limited life expectancy (\< six months)
2. Any progressive brain illness, such as a brain tumor or neurodegenerative disease
3. Pre-admission Glasgow Outcome Scale score of 3 or lower
4. Reason other than the neurological condition to withdraw treatment
5. EEG background activity prior to the emergence of ESE indicative of extensive irreversible anoxic brain injury
6. Follow-up impossible due to logistic reasons, for example not living in the Netherlands or Belgium

Where it's running

• Hôpital Universitaire de Bruxelles
  Brussels, Belgium Recruiting
• Universitair Ziekenhuis Brussel
  Brussels, Belgium Recruiting
• Centre Hospitalier Universitaire Marie Curie
  Charleroi, Belgium Recruiting
• Centre Hospitalier Chrétien - MontLégia
  Liège, Belgium Recruiting
• Centre Hospitalier Universitaire Sart-Tilmant
  Liège, Belgium Recruiting
• Centre Hospitalier Universitaire Tivoli
  Louvière, Belgium Recruiting

Study contacts

• Principal investigator: Jeannette Hofmeijer, MD — University of Twente
• Study coordinator: Jeannette Hofmeijer, MD
• Email: j.hofmeijer@utwente.nl
• Phone: +31 53 489 4835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.