Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design
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 th...
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| Series: | Stroke and Vascular Neurology |
| Online Access: | https://svn.bmj.com/content/early/2024/01/30/svn-2023-002868.full |
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| author | Yue Wang Xiaoqiu Li Lu Wang Yi Yang Thanh Nguyen Hui-Sheng Chen Zhenni Guo |
| author_facet | Yue Wang Xiaoqiu Li Lu Wang Yi Yang Thanh Nguyen Hui-Sheng Chen Zhenni Guo |
| author_sort | Yue Wang |
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| description | 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. |
| format | Article |
| id | doaj-art-8edf160b1bdb40e7bc2c62246e68e5fc |
| institution | Kabale University |
| issn | 2059-8696 |
| language | English |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Stroke and Vascular Neurology |
| spelling | doaj-art-8edf160b1bdb40e7bc2c62246e68e5fc2024-11-10T12:25:09ZengBMJ Publishing GroupStroke and Vascular Neurology2059-869610.1136/svn-2023-002868Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and designYue Wang0Xiaoqiu Li1Lu Wang2Yi Yang3Thanh Nguyen4Hui-Sheng Chen5Zhenni Guo6Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China2 Department of Otolaryngology Head and Neck Surgery, Shenzhen University General Hospital, Shenzhen, Guangdong, ChinaKidney disease center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, ChinaNeurology, Radiology, Boston Medical Center, Boston, Massachusetts, USADepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, ChinaThe First Hospital of Jilin University, Changchun, Jilin, ChinaRationale 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.https://svn.bmj.com/content/early/2024/01/30/svn-2023-002868.full |
| spellingShingle | Yue Wang Xiaoqiu Li Lu Wang Yi Yang Thanh Nguyen Hui-Sheng Chen Zhenni Guo Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design Stroke and Vascular Neurology |
| title | Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design |
| title_full | Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design |
| title_fullStr | Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design |
| title_full_unstemmed | Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design |
| title_short | Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design |
| title_sort | trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology hopes 3 rationale and design |
| url | https://svn.bmj.com/content/early/2024/01/30/svn-2023-002868.full |
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