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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Hôpital Universitaire de Bruxelles
RECRUITING
Brussels
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
Centre Hospitalier Universitaire Marie Curie
RECRUITING
Charleroi
Centre Hospitalier Chrétien - MontLégia
RECRUITING
Liège
Centre Hospitalier Universitaire Sart-Tilmant
RECRUITING
Liège
Centre Hospitalier Universitaire Tivoli
RECRUITING
Louvière
Centre Hospitalier Universitaire Saint-Pierre
RECRUITING
Ottignies
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Rijnstate Hospital
RECRUITING
Arnhem
Amphia Ziekenhuis
NOT_YET_RECRUITING
Breda
Catharina Hospital
RECRUITING
Eindhoven
Medical Spectrum Twente
RECRUITING
Enschede
University Medical Center Groningen
RECRUITING
Groningen
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
St. Antonius Hospital
RECRUITING
Nieuwegein
Canisius Wilhelmina Hospital
ACTIVE_NOT_RECRUITING
Nijmegen
Radboud University Medical Center
RECRUITING
Nijmegen
Erasmus University Medical Center
RECRUITING
Rotterdam
Maasstad Hospital
RECRUITING
Rotterdam
Haga Ziekenhuis
NOT_YET_RECRUITING
The Hague
VieCuri Medical Center
RECRUITING
Venlo
Contact Information
Primary
Jeannette Hofmeijer, MD
j.hofmeijer@utwente.nl
+31 53 489 4835
Backup
Nicolas Gaspard, MD
nicolas.gaspard@hubruxelles.be
+32 2 555 46 22
Time Frame
Start Date:2025-04-10
Estimated Completion Date:2030-12
Participants
Target number of participants:150
Treatments
Other: Intervention group
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.
Collaborators: Belgium Health Care Knowledge Centre, Erasme University Hospital, ZonMw: The Netherlands Organisation for Health Research and Development