Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design.

Autor:	Li X; Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China., Guo Z; The First Hospital of Jilin University, Changchun, Jilin, China., Wang L; Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China., Wang Y; Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China., Nguyen T; Neurology, Radiology, Boston Medical Center, Boston, Massachusetts, USA., Yang Y; The First Hospital of Jilin University, Changchun, Jilin, China.; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin, China., Chen HS; Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China chszh@aliyun.com.
Jazyk:	angličtina
Zdroj:	Stroke and vascular neurology [Stroke Vasc Neurol] 2024 Nov 05; Vol. 9 (5), pp. 574-579. Date of Electronic Publication: 2024 Nov 05.
DOI:	10.1136/svn-2023-002868
Abstrakt:	Rationale: The effect of the head position as a non-pharmacological therapy on acute ischaemic stroke (AIS) remains inconclusive. Our recent Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis (HOPES 2) suggested the safety, feasibility and potential benefit of the head-down position (HDP) in AIS. Aim: To investigate the benefit of HDP in acute moderate ischaemic stroke patients with large artery atherosclerosis (LAA). Sample Size Estimates: Based on a two-sided 0.05 level of significance, 600 patients are expected to yield the superiority hypothesis with 80% power, stratified by age, sex, history of diabetes, baseline systolic blood pressure, location of index vessel, National Institutes of Health Stroke Scale Score at randomisation, onset to randomisation time, progression to moderate neurological deficit due to early neurological deterioration and degree of responsible vessel stenosis. Design: Head dOwn-Position for acutE moderate ischaemic Stroke with large artery atherosclerosis(HOPES 3) is a prospective, randomised, open-label, blinded endpoint and multicentre study. Eligible patients who had an ischaemic stroke will be randomly assigned (1:1) into the HDP group receiving -20° Trendelenburg plus standard medical care in compliance with national guidelines, or control group only receiving standard medical care in compliance with national guidelines. Outcome: The primary outcome is favourable functional outcome, defined as modified Rankin Scale 0-2 at 90 days. Safety outcomes are HDP-related adverse events. All outcomes will have blinded assessment and will be analysed on the intention-to-treat basis. Conclusions: The results of HOPES 3 will provide evidence for the effect of HDP in acute moderate ischaemic stroke patients with LAA within 24 hours of onset or in patients with progression from mild neurological deficit within 24 hours. Trial Registration Number: NCT06010641. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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