Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
SENSEII/AROUSE
1 other identifier
observational
3,000
8 countries
11
Brief Summary
SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 3, 2023
March 1, 2023
5.8 years
March 23, 2023
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Refractoriness
Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Secondary Outcomes (3)
Modified Rankin Scale
At 30 days after the date of inclusion or SE onset (if still hospitalized)
Modified Rankin Scale
At 3 months after the date of discharge from hospital
Super-refractoriness
From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Eligibility Criteria
All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay
You may qualify if:
- 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
You may not qualify if:
- \- Patients with post-cardiac arrest SE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Kepler University Linz
Linz, Austria
Christian Doppler Klinik of Paracelsus Medical University
Salzburg, Austria
HUB Erasme
Brussels, 1070, Belgium
Odense University Hospital & Svenborg Hospital
Odense, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Goethe-Universität Frankfurt am Main
Frankfurt, Germany
Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück
Osnabrück, D-49078, Germany
Oslo University Hospital
Oslo, Norway
University Hospital Basel
Basel, Switzerland
University Hospital of Geneva
Geneva, Switzerland
Birmingham University Hospitals NHS Trust
Birmingham, United Kingdom
Related Publications (1)
Damien C, Leitinger M, Kellinghaus C, Strzelczyk A, De Stefano P, Beier CP, Sutter R, Kamppi L, Strbian D, Tauboll E, Rosenow F, Helbok R, Ruegg S, Damian M, Trinka E, Gaspard N. Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505-y.
PMID: 38178048DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Gaspard, MD, PhD
Erasme UH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
May 3, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
May 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be deidentified and collected through RedCap by each local investigator. IPD will be accessible and shared only with the researchers involved in this registry. These de-identified data will be available for the duration of the registry and on reasonable request to Nicolas Gaspard after publication of the results.
- Access Criteria
- IPD will be accessible only by the researchers involved in the building of this registry.
All collected IPD will be shared with other researchers. not public upon reasonable request