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Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245866
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
University of Bern
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Ospedale Regionale di Lugano
University Hospital, Zürich
Cantonal Hospital of St. Gallen
University of Lausanne Hospitals
Information provided by (Responsible Party):
Philippe Bijlenga, University Hospital, Geneva

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.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Intracranial Aneurysm Other: Observational/ no intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)
Actual Study Start Date : January 1, 2009
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Aneurysmal Subarachnoid hemorrhage
Patients suffering from a ruptured cerebral aneurysm are included in the study.
Other: Observational/ no intervention



Primary Outcome Measures :
  1. Functional outcome as assessed by the modified Rankin scale [ Time Frame: 5 years after hemorrhage ]

    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted in Switzerland with a diagnosis of aneurysmal subarachnoid hemorrhage
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245866


Contacts
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Contact: Karl Schaller, MD +41223728202 karl.schaller@hcuge.ch
Contact: Philippe Bijlenga, MD PhD +41792044043 philippe.bijlenga@hcuge.ch

Locations
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Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5000
Contact: Serge Marbacher, MD       serge.marbacher@ksa.ch   
Contact: Javier Fandino, MD       javier.fandino@ksa.ch   
Geneva University Hospital Recruiting
Geneva, GE, Switzerland, 1211
Contact: Karl Schaller, MD    +41223728202    karl.schaller@hcuge.ch   
Contact: Philippe Bijlenga, MD, PhD    +41223723246    philippe.bijlenga@hcuge.ch   
Principal Investigator: Karl Schaller, MD         
Principal Investigator: Martin N Stienen, MD         
Principal Investigator: Philippe Bijlenga, MD         
Principal Investigator: Bawarjan Schatlo, MD         
Kantonsspital St. Gallen Recruiting
St. Gallen, Saint Gallen, Switzerland, 9000
Contact: Martin Seule, MD       martin.seule@kssg.ch   
University Hospital Basel Recruiting
Basel, Switzerland, 4000
Contact: Daniel Zumofen, MD       daniel.zumofen@gmail.com   
Contact: Michel Roethlisberger, MD       coles@bluewin.ch   
University Hospital Bern Recruiting
Bern, Switzerland, 3000
Contact: David Bervini, MD       david.bervini@insel.ch   
University Hospital Lausanne Recruiting
Lausanne, Switzerland, 1000
Contact: Rodolfo Maduri, MD       rodolfo.maduri@gmail.com   
Contact: Roy T Daniel, MD       roy.daniel@chuv.ch   
Principal Investigator: Rodolfo Maduri, MD         
Ospedale Civico Recruiting
Lugano, Switzerland, 6900
Contact: Michael Reinert, MD       michael.reinert@eoc.ch   
Contact: Daniel Valsecchi, MD       daniele.valsecchi@eoc.ch   
Principal Investigator: Thomas Robert, MD         
Luzerner Kanton Spital Recruiting
Luzern, Switzerland, 6000
Contact: Karl F. Kothbauer, MD    +41412055740    Karl.Kothbauer@luks.ch   
University Hospital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Emanuela Keller, MD       emanuela.keller@usz.ch   
Contact: Jan-Karl Burkhardt, MD       jan-karl.burkhardt@usz.ch   
Sponsors and Collaborators
University Hospital, Geneva
University of Bern
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Ospedale Regionale di Lugano
University Hospital, Zürich
Cantonal Hospital of St. Gallen
University of Lausanne Hospitals
Investigators
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Study Director: Karl Schaller, MD University Hospital, Geneva
Principal Investigator: Bawarjan Schatlo, MD University Hospital, Geneva
Principal Investigator: Martin N Stienen, MD University Hospital, Geneva
Principal Investigator: Philippe Bijlenga, MD PhD University Hospital, Geneva
Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philippe Bijlenga, MD PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03245866    
Other Study ID Numbers: SwissSOS_0001
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, observational study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Bijlenga, University Hospital, Geneva:
Subarachnoid Hemorrhage
Intracranial Aneurysm
Ruptured Intracranial Aneurysm
Neurosurgery
Interventional Neuroradiology
Neurointensive Care Medicine
Switzerland
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Intracranial Aneurysm
Aneurysm
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases