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Subarachnoid HemorrhageSwiss-SOSNCT03245866

Swiss Study on Subarachnoid Hemorrhage

An observational study of Subarachnoid Hemorrhage and Intracranial Aneurysm, run by University Hospital, Geneva at 9 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Any age
How many people
5,000 participants
Where
9 sitesSwitzerland
Study dates
1 Jan 2009to 31 Dec 2030
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karl Schaller, MD contact

+41223728202

karl.schaller@hcuge.ch

Philippe Bijlenga, MD PhD contact

+41792044043

philippe.bijlenga@hcuge.ch

9 sites in 1 country

Switzerland9 sites, 9 recruiting

  • Kantonsspital Aarau

    Aarau, Canton of Aargau, 5000

    Serge Marbacher, MD, serge.marbacher@ksa.ch

    Recruiting

  • University Hospital Basel

    Basel, 4000

    Raphael Guzman, MD, raphael.guzman@ukbb.ch

    Michel Roethlisberger, MD, coles@bluewin.ch

    Recruiting

  • University Hospital Bern

    Bern, 3000

    David Bervini, MD, david.bervini@insel.ch

    Recruiting

  • Geneva University Hospital

    Geneva, Canton of Geneva, 1211

    Karl Schaller, MD, +41223728202, karl.schaller@hcuge.ch

    Philippe Bijlenga, MD, PhD, +41223723246, philippe.bijlenga@hcuge.ch

    Recruiting

  • University Hospital Lausanne

    Lausanne, 1000

    Roy T Daniel, MD, roy.daniel@chuv.ch

    MD

    Recruiting

  • Luzerner Kanton Spital

    Lucerne, 6000

    Alexander F. vonhessling, MD, alexander.vonhessling@luks.ch

    Recruiting

  • Ospedale Civico

    Lugano, 6900

    Thoams Robert, MD, Thomas.Robert@eoc.ch

    MD

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9000

    Martin Seule, MD, martin.seule@kssg.ch

    Recruiting

  • University Hospital Zürich

    Zurich, 8091

    Emanuela Keller, MD, emanuela.keller@usz.ch

    Jan-Karl Burkhardt, MD, jan-karl.burkhardt@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

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.

Read the 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.

Being tested
Observational/ no intervention
Keywords
Subarachnoid Hemorrhage, Intracranial Aneurysm, Ruptured Intracranial Aneurysm, Neurosurgery, Interventional Neuroradiology, Neurointensive Care Medicine, Switzerland
Medical subject headings
Subarachnoid Hemorrhage, Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational/ no interventionOther

Study groups in NCT03245866
Study groupRoleWhat they receive
Aneurysmal Subarachnoid hemorrhagePatients suffering from a ruptured cerebral aneurysm are included in the study.
Receives: Other: Observational/ no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years after hemorrhage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start1 Jan 2009
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245866
Sponsor's protocol ID
SwissSOS_0001
Acronym
Swiss-SOS
Status last verified
May 2023
First submitted
23 Aug 2015
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: N/A, observational study

Publications

  • 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.

    PubMed 26179382

  • 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.

    PubMed 23053275

  • 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.

    PubMed 33272133

  • 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.

    PubMed 30735342

  • 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.

    PubMed 29335333

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage and Intracranial Aneurysm, run by University Hospital, Geneva at 9 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karl Schaller, MD (+41223728202, karl.schaller@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome as assessed by the modified Rankin scale (time frame: 5 years after hemorrhage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245866, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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