Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)
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|ClinicalTrials.gov Identifier: NCT03245866|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment|
|Subarachnoid Hemorrhage Intracranial Aneurysm||Other: Observational/ no intervention|
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 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
Aneurysmal Subarachnoid hemorrhage
Patients suffering from a ruptured cerebral aneurysm are included in the study.
Other: Observational/ no intervention
- 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.
- - 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.
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
|Contact: Karl Schaller, MDfirstname.lastname@example.org|
|Contact: Philippe Bijlenga, MD PhDemail@example.com|
|Aarau, Aargau, Switzerland, 5000|
|Contact: Serge Marbacher, MD firstname.lastname@example.org|
|Contact: Javier Fandino, MD email@example.com|
|Geneva University Hospital||Recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Karl Schaller, MD +41223728202 firstname.lastname@example.org|
|Contact: Philippe Bijlenga, MD, PhD +41223723246 email@example.com|
|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 firstname.lastname@example.org|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4000|
|Contact: Daniel Zumofen, MD email@example.com|
|Contact: Michel Roethlisberger, MD firstname.lastname@example.org|
|University Hospital Bern||Recruiting|
|Bern, Switzerland, 3000|
|Contact: David Bervini, MD email@example.com|
|University Hospital Lausanne||Recruiting|
|Lausanne, Switzerland, 1000|
|Contact: Rodolfo Maduri, MD firstname.lastname@example.org|
|Contact: Roy T Daniel, MD email@example.com|
|Principal Investigator: Rodolfo Maduri, MD|
|Lugano, Switzerland, 6900|
|Contact: Michael Reinert, MD firstname.lastname@example.org|
|Contact: Daniel Valsecchi, MD email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jan-Karl Burkhardt, MD email@example.com|
|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|