Treatment for brain activity issues after cardiac arrest
Treatment of ELectrographic STatus Epilepticus After Cardiopulmonary Resuscitation-2: Multicenter Randomised Clinical Trial and Health Economic Evaluation of Anti-seizure Treatment in Comatose Cardiac Arrest Patients With SE on Continuous EEG
This study tests if giving anti-seizure medication to comatose patients after cardiac arrest can help them recover better than those who don’t receive it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Twente Academic / other |
| Locations | 20 sites (Brussels and 19 other locations) |
| Trial ID | NCT06549426 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are in a coma after out-of-hospital cardiac arrest and have been diagnosed with ESE.
Not a fit: Patients with known progressive brain illnesses or those with a Glasgow Outcome Scale score of 3 or lower prior to admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for comatose patients after cardiac arrest.
How similar studies have performed: Previous studies have shown mixed results regarding the treatment of electrographic status epilepticus, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brussels and 19 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.