Registry for patients treated for Status Epilepticus
Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
This study is trying to gather information about adults with Status Epilepticus to see how different treatments and their outcomes vary across various hospitals in Europe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasme University Hospital Academic / other |
| Locations | 11 sites (Linz and 10 other locations) |
| Trial ID | NCT05839418 on ClinicalTrials.gov |
What this trial studies
SENSE-II/AROUSE is a prospective, multicenter registry aimed at documenting the characteristics, treatment modalities, EEG features, and outcomes of adults admitted for Status Epilepticus (SE) across various medical centers in Europe. The study will collect clinical and EEG data from patient admission to discharge using electronic data capture tools. By including both university and non-university hospitals, the study seeks to enhance the generalizability of its findings and identify predictors of outcomes and refractoriness in SE management. A target cohort size of 3000 patients is set to ensure sufficient statistical power for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are admitted for management of Status Epilepticus.
Not a fit: Patients with anoxic Status Epilepticus following cardiac arrest will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of Status Epilepticus, leading to better patient outcomes.
How similar studies have performed: While there have been limited prospective controlled trials in this area, the registry approach has the potential to fill gaps in knowledge and management practices for Status Epilepticus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or above * Patients admitted for management of Status Epilepticus as their primary diagnosis * Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay Exclusion Criteria: \- Patients with post-cardiac arrest SE
Where this trial is running
Linz and 10 other locations
- Kepler University Linz — Linz, Austria (Not_yet_recruiting)
- Christian Doppler Klinik of Paracelsus Medical University — Salzburg, Austria (Not_yet_recruiting)
- HUB Erasme — Brussels, Belgium (Recruiting)
- Odense University Hospital & Svenborg Hospital — Odense, Denmark (Recruiting)
- Helsinki University Central Hospital — Helsinki, Finland (Not_yet_recruiting)
- Goethe-Universität Frankfurt am Main — Frankfurt, Germany (Not_yet_recruiting)
- Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück — Osnabrück, Germany (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- University Hospital Basel — Basel, Switzerland (Not_yet_recruiting)
- University Hospital of Geneva — Geneva, Switzerland (Not_yet_recruiting)
- Birmingham University Hospitals NHS Trust — Birmingham, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Nicolas Gaspard, MD, PhD — Erasme UH
- Study coordinator: Nicolas Gaspard, MD, PhD
- Email: Nicolas.Gaspard@erasme.ulb.ac.be
- Phone: 00325553429
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.