Swiss Study on Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— Swiss-SOS  

Official title:

Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245866
• Other study ID #: SwissSOS_0001
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: Karl Schaller, MD
• Phone: +41223728202
• Email: karl.schaller[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

Other:
• Observational/ no intervention

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Aargau
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Bern	Bern
Switzerland	Geneva University Hospital	Geneva	GE
Switzerland	University Hospital Lausanne	Lausanne
Switzerland	Ospedale Civico	Lugano
Switzerland	Luzerner Kanton Spital	Luzern
Switzerland	Kantonsspital St. Gallen	St. Gallen	Saint Gallen
Switzerland	University Hospital Zürich	Zürich

Sponsors (8)

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

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Schatlo B, Fung C, Fathi AR, Sailer M, Winkler K, Daniel RT, Bijlenga P, Ahlborn P, Seule M, Zumofen D, Reinert M, Woernle C, Stienen M, Levivier M, Hildebrandt G, Mariani L, Bernays R, Fandino J, Raabe A, Keller E, Schaller K. Introducing a nationwide re — View Citation

Zweifel-Zehnder AE, Stienen MN, Chicherio C, Studerus-Germann A, Blasi S, Rossi S, Gutbrod K, Schmid N, Beaud V, Mondadori C, Brugger P, Sacco L, Muri R, Hildebrandt G, Fournier JY, Keller E, Regli L, Fandino J, Mariani L, Raabe A, Daniel RT, Reinert M, Robert T, Schatlo B, Bijlenga P, Schaller K, Monsch AU; Swiss SOS study group. Call for uniform neuropsychological assessment after aneurysmal subarachnoid hemorrhage: Swiss recommendations. Acta Neurochir (Wien). 2015 Sep;157(9):1449-58. doi: 10.1007/s00701-015-2480-y. Epub 2015 Jul 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome as assessed by the modified Rankin scale	The 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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	5 years after hemorrhage