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Swiss Study on Subarachnoid Hemorrhage

Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03245866
Acronym
Swiss-SOS
Enrollment
5000
Registered
2017-08-10
Start date
2009-01-01
Completion date
2030-12-31
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm, Subarachnoid Hemorrhage

Keywords

Subarachnoid Hemorrhage, Intracranial Aneurysm, Ruptured Intracranial Aneurysm, Neurosurgery, Interventional Neuroradiology, Neurointensive Care Medicine, Switzerland

Brief summary

This registry was created to assess management parameters of patients treated for aneurysmal subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department, an intensive care unit and an interventional neuroradiology team that treat neurovascular emergencies participate in the registry. Clinical parameters are entered into a common database. This database will provide (1) a nationwide assessment of the current standard of care and (2) the outcomes for patients in Switzerland including neuropsychological assessments.

Detailed description

Overview: The management of aneurysmal subarachnoid hemorrhage (aSAH) in Switzerland has not been assessed on a national level to date. The investigators united all comprehensive neurovascular care centres in Switzerland to create a registry for aSAH. This registry helps collect clinical and management data from different centres and pools it in one common database. It may provide referring caregivers and healthcare providers with a critical tool to assess the quality of care in a disease which has a high socio-economic burden. Moreover, it may serve as a tool to foster scientific collaboration and address a number of remaining questions about the management of aSAH in the future. Regarding SAH, data from the federal statistics bureau of Switzerland are based strictly on ICD-10 codes provided by hospitals and show an estimate of 13 per 100,000 in a population of roughly 8 million (http://bfs.admin.ch). These numbers, however, are not referring to aneurismal SAH exclusively and thus exceed the numbers which the investigators expect to obtain. The goal is to obtain complete recruitment of SAH patients throughout Switzerland, and the goal is therefore that assessment of incidence will be performed later on. Data management: Data is entered into a central online database created by the Secutrial platform. This platform is provided by the University Hospital of Geneva's Clinical Research Unit. The database disposes of an audit-trail capacity. Local principal investigators are responsible for data-cross check and quality management. Source data verification is performed by investigators on site who address missing data. Regular meetings are held to discuss data patency. The platform automatically provides a report on recruitment progress.

Interventions

OTHERObservational/ no intervention

Sponsors

University of Bern
CollaboratorOTHER
University Hospital, Basel, Switzerland
CollaboratorOTHER
Kantonsspital Aarau
CollaboratorOTHER
Ospedale Regionale di Lugano
CollaboratorOTHER
University Hospital, Zürich
CollaboratorOTHER
Cantonal Hospital of St. Gallen
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

\- Patients admitted with a proven diagnosis of aneurysmal subarachnoid hemorrhage.

Exclusion criteria

\- Patients in whom the source of haemorrhage could not be identified (angiogram-negative SAH) or SAH with other causes than cerebral aneurysms.

Design outcomes

Primary

MeasureTime frameDescription
Functional outcome as assessed by the modified Rankin scale5 years after hemorrhageThe modified Rankin scale is used to represent the level of disability and is divided into 7 categories (0-6). The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

Countries

Switzerland

Contacts

Primary ContactKarl Schaller, MD
karl.schaller@hcuge.ch+41223728202
Backup ContactPhilippe Bijlenga, MD PhD
philippe.bijlenga@hcuge.ch+41792044043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026