Recruiting

NCT Number: NCT03245866

Swiss Study on Subarachnoid Hemorrhage

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.

Recruiting

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Aarau, Aarau, Canton of Aargau, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational/ no intervention

Other

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karl Schaller, MD

CONTACT

[email protected]

+41223728202

Philippe Bijlenga, MD PhD

CONTACT

[email protected]

+41792044043

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

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

Registry information

Official study title

Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)

Acronym: Swiss-SOS

Important dates

Study start: 2009
Primary completion: 2025
Study completion: 2030
First posted: Aug 10, 2017
Registry last updated: May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed