Swiss Study on Subarachnoid Hemorrhage

Recruiting

• Conditions: Intracranial Aneurysm; Subarachnoid Hemorrhage
• Interventions: Other: Observational/ no intervention

• Registration Number: NCT03245866
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Functional outcome as assessed by the modified Rankin scale	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.

Trial Locations

Locations (9)

Kantonsspital Aarau; 🇨🇭 Aarau, Aargau, Switzerland

Geneva University Hospital; 🇨🇭 Geneva, GE, Switzerland

Ospedale Civico; 🇨🇭 Lugano, Switzerland

Luzerner Kanton Spital; 🇨🇭 Luzern, Switzerland

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland

University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland