Swiss Study on Subarachnoid Hemorrhage

NCT03245866 | Recruiting DMC

• 1 other identifier: SwissSOS_0001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  5 years after hemorrhage

Study Arms (1)

Aneurysmal Subarachnoid hemorrhage

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

Other: Observational/ no intervention

Interventions

Observational/ no intervention OTHER

Aneurysmal Subarachnoid hemorrhage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted in Switzerland with a diagnosis of aneurysmal subarachnoid hemorrhage

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Bern: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Kantonsspital Aarau: collaborator
• Ospedale Regionale di Lugano: collaborator
• University Hospital, Zürich: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (9)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5000, Switzerland

RECRUITING

Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

RECRUITING

University Hospital Basel

Basel, 4000, Switzerland

RECRUITING

University Hospital Bern

Bern, 3000, Switzerland

RECRUITING

University Hospital Lausanne

Lausanne, 1000, Switzerland

RECRUITING

Luzerner Kanton Spital

Lucerne, 6000, Switzerland

RECRUITING

Ospedale Civico

Lugano, 6900, Switzerland

RECRUITING

University Hospital Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (5)

• 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.

  PMID: 26179382 BACKGROUND

• 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.

  PMID: 23053275 RESULT

• 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.

  PMID: 33272133 DERIVED

• 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.

  PMID: 30735342 DERIVED

• 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.

  PMID: 29335333 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Karl Schaller, MD

  University Hospital, Geneva

  STUDY DIRECTOR

• Bawarjan Schatlo, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Martin N Stienen, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Philippe Bijlenga, MD PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Schaller, MD

CONTACT

+41223728202; karl.schaller@hcuge.ch

Philippe Bijlenga, MD PhD

CONTACT

+41792044043; philippe.bijlenga@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 10, 2017
• Study Start: January 1, 2009
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (9)