Clinical features, management and outcomes of severe ischaemic stroke in tertiary hospitals in China: protocol for a prospective multicentre registry-based observational study

Abstract

Introduction: Severe ischaemic stroke is a devastating condition with high mortality and morbidity; however, there is insufficient evidence on its management. The aim of this study is to investigate causes, risk factors, clinical course, management and outcomes of severe ischaemic stroke in a real-world setting in tertiary hospitals in China.

Methods and analysis: This is a prospective, multicentre, registry-based observational study. We will recruit 2500 patients with acute ischaemic stroke from nine tertiary hospitals in Western China. Patients with acute ischaemic stroke admitted to the Department of Neurology within 30 days of stroke onset will be included. Patients will be visited within 24 hours after admission, on day 3, day 7 and at discharge, to collect data on their clinical state, blood biomarkers and brain imaging. Severe stroke is defined as severe neurological deficits (National Institute of Health Stroke Scale (NIHSS) ≥15 or in coma) on admission or clinical worsening (NIHSS increased by ≥4 scores) during hospitalisation. Patients will be followed up by structured telephone interviews at 3 months and 1 year after stroke onset. In-hospital outcomes include symptomatic haemorrhagic transformation and brain oedema by day 7 of admission, and survival status (death or survival) by discharge; follow-up outcomes will include survival status and functional outcome (assessed by modified Rankin Scale) at 3 months and 1 year. The current study will improve our knowledge about the development of severe ischaemic stroke at acute phase and factors influencing its outcomes, which will eventually facilitate optimisation of individualised interventions for its prevention and treatment.

Ethics and dissemination: Ethics approval is obtained from The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2017(130)). We will present our findings at the national and international conferences and peer-reviewed journals in stroke and neurology.

Trial registration number: NCT03222024; Pre-results.

Keywords: ischaemic stroke; malignant; management; prognosis; risk factors; severe.