Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

May 15, 2023 updated by: Philippe Bijlenga, University Hospital, Geneva

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4000
      • Bern, Switzerland, 3000
      • Lausanne, Switzerland, 1000
        • Recruiting
        • University Hospital Lausanne
        • Contact:
        • Principal Investigator:
          • Rodolfo Maduri, MD
        • Contact:
          • MD
      • Lugano, Switzerland, 6900
        • Recruiting
        • Ospedale Civico
        • Principal Investigator:
          • Thomas Robert, MD
        • Contact:
          • MD
        • Contact:
      • Luzern, Switzerland, 6000
      • Zürich, Switzerland, 8091
    • Aargau
      • Aarau, Aargau, Switzerland, 5000
    • GE
      • Geneva, GE, Switzerland, 1211
        • Recruiting
        • Geneva University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karl Schaller, MD
        • Principal Investigator:
          • Martin N Stienen, MD
        • Principal Investigator:
          • Philippe Bijlenga, MD
        • Principal Investigator:
          • Bawarjan Schatlo, MD
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years after hemorrhage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

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

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SwissSOS_0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/A, observational study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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