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Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial

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机构: [1]Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China. [2]Department of Neurology, Fengtai Youanmen Hospital, Beijing, China. [3]Intensive Care Unit, Renhe Hospital, Beijing, China. [4]Department of Neurology, Hebei Province Shunping County Hospital, Baoding, Hebei, China. [5]Xuanwu Hospital Capital Medical University, Beijing, China wuchuanjie@ccmu.edu.cn.
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Intracerebral haemorrhage (ICH) is a neurological emergency with high morbidity and mortality, and current treatment is limited. Emerging evidence has reported that statins can exert neuroprotective effects in cerebrovascular diseases. However, most of the published clinical studies are retrospective. Therefore, it is important to conduct a prospective randomised controlled trial to further validate the efficacy and safety of statins in patients with ICH.The present study is performed at Xuan Wu Hospital Capital Medical University, Beijing Fengtai You'anmen Hospital and Shunping County Hospital, Hebei Province. The target number of patients is 98. Eligible patients are randomly assigned in a 1:1 ratio to the statins group or the control group. The primary outcome is the perihaemorrhagic oedema to haematoma ratio at 7 days. Secondary outcomes include mortality at 30 days, haematoma resolution rate at 7 days, National Institute of Health stroke scale (NIHSS) score at 7 days or discharge, ordinal distribution of modified Rankin scale (mRS) score at 90 days, the proportion of patients with an mRS score of 0-2 on day 90, the proportion of patients with an mRS score of 0-3 on day 90, absolute haematoma volume changes between initial and 7-day follow-up CT scan, absolute perihaematomal oedema changes between initial and 7-day follow-up CT scan.The trial has been approved by the ethics committees of Xuan Wu Hospital Capital Medical University, Beijing Fengtai You'anmen Hospital and Shunping County Hospital, Hebei Province. The results will be disseminated in a peer-reviewed journal and in conference reports.NCT04857632.© 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.

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出版当年[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
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出版当年[2022]版:
Q2 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China.
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