Swiss Study on Subarachnoid Hemorrhage

NCT ID: NCT03245866

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Subarachnoid Hemorrhage Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysmal Subarachnoid hemorrhage

Patients suffering from a ruptured cerebral aneurysm are included in the study.

Observational/ no intervention

Intervention Type OTHER

Interventions

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Observational/ no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Kantonsspital Aarau

OTHER

Sponsor Role collaborator

Ospedale Regionale di Lugano

OTHER

Sponsor Role collaborator

University Hospital, Zürich

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Philippe Bijlenga

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Schaller, MD

Role: STUDY_DIRECTOR

University Hospital, Geneva

Bawarjan Schatlo, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Martin N Stienen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Philippe Bijlenga, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Site Status RECRUITING

Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University Hospital Bern

Bern, , Switzerland

Site Status RECRUITING

University Hospital Lausanne

Lausanne, , Switzerland

Site Status RECRUITING

Luzerner Kanton Spital

Lucerne, , Switzerland

Site Status RECRUITING

Ospedale Civico

Lugano, , Switzerland

Site Status RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Karl Schaller, MD

Role: CONTACT

+41223728202

Philippe Bijlenga, MD PhD

Role: CONTACT

+41792044043

Facility Contacts

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Serge Marbacher, MD

Role: primary

Karl Schaller, MD

Role: primary

+41223728202

Philippe Bijlenga, MD, PhD

Role: backup

+41223723246

Martin Seule, MD

Role: primary

Raphael Guzman, MD

Role: primary

Michel Roethlisberger, MD

Role: backup

David Bervini, MD

Role: primary

Roy T Daniel, MD

Role: primary

MD

Role: backup

Alexander F. vonhessling, MD

Role: primary

Thoams Robert, MD

Role: primary

MD

Role: backup

Emanuela Keller, MD

Role: primary

Jan-Karl Burkhardt, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26179382 (View on PubMed)

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 registry: the Swiss study on aneurysmal subarachnoid haemorrhage (Swiss SOS). Acta Neurochir (Wien). 2012 Dec;154(12):2173-8; discussion 2178. doi: 10.1007/s00701-012-1500-4. Epub 2012 Oct 6.

Reference Type RESULT
PMID: 23053275 (View on PubMed)

Schatlo B, Fung C, Stienen MN, Fathi AR, Fandino J, Smoll NR, Zumofen D, Daniel RT, Burkhardt JK, Bervini D, Marbacher S, Reinert M, D Alonzo D, Ahlborn P, Mendes Pereira V, Roethlisberger M, Seule M, Kerkeni H, Remonda L, Weyerbrock A, Woernle K, Venier A, Perren F, Sailer M, Robert T, Rohde V, Schoni D, Goldberg J, Nevzati E, Diepers M, Gralla J, Z'Graggen W, Starnoni D, Woernle C, Maldaner N, Kulcsar Z, Mostaguir K, Maduri R, Eisenring C, Bernays R, Ferrari A, Dan-Ura H, Finkenstadt S, Gasche Y, Sarrafzadeh A, Jakob SM, Corniola M, Baumann F, Regli L, Levivier M, Hildebrandt G, Landolt H, Mariani L, Guzman R, Beck J, Raabe A, Keller E, Bijlenga P, Schaller K. Incidence and Outcome of Aneurysmal Subarachnoid Hemorrhage: The Swiss Study on Subarachnoid Hemorrhage (Swiss SOS). Stroke. 2021 Jan;52(1):344-347. doi: 10.1161/STROKEAHA.120.029538. Epub 2020 Dec 4.

Reference Type DERIVED
PMID: 33272133 (View on PubMed)

Stienen MN, Smoll NR, Fung C, Goldberg J, Bervini D, Maduri R, Chiappini A, Robert T, May A, Bijlenga P, Zumofen D, Roethlisberger M, Seule MA, Marbacher S, Fandino J, Schatlo B, Schaller K, Keller E, Bozinov O, Regli L; Swiss SOS Study Group. Home-Time as a Surrogate Marker for Functional Outcome After Aneurysmal Subarachnoid Hemorrhage. Stroke. 2018 Dec;49(12):3081-3084. doi: 10.1161/STROKEAHA.118.022808.

Reference Type DERIVED
PMID: 30735342 (View on PubMed)

Stienen MN, Germans M, Burkhardt JK, Neidert MC, Fung C, Bervini D, Zumofen D, Rothlisberger M, Marbacher S, Maduri R, Robert T, Seule MA, Bijlenga P, Schaller K, Fandino J, Smoll NR, Maldaner N, Finkenstadt S, Esposito G, Schatlo B, Keller E, Bozinov O, Regli L; Swiss SOS Study Group. Predictors of In-Hospital Death After Aneurysmal Subarachnoid Hemorrhage: Analysis of a Nationwide Database (Swiss SOS [Swiss Study on Aneurysmal Subarachnoid Hemorrhage]). Stroke. 2018 Feb;49(2):333-340. doi: 10.1161/STROKEAHA.117.019328. Epub 2018 Jan 15.

Reference Type DERIVED
PMID: 29335333 (View on PubMed)

Other Identifiers

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SwissSOS_0001

Identifier Type: -

Identifier Source: org_study_id

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