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Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial

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机构: [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China, [2]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China, [3]Clinical Stroke Research Unit, Xuanwu Hospital, Capital Medical University, Beijing, China, [4]Department of Neurology, Ningjin County Hospital, Xingtai, China, [5]Department of Neurosurgery, Heze Municipal Hospital, Heze, China, [6]Department of Neurosurgery, The Sixth Hospital of Hengshui, Hengshui, China, [7]Department of Neurology, Shengli Oilfield Central Hospital, Dongying, China, [8]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China
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关键词: intracerebral hemorrhage hematoma resolution remote ischemic conditioning randomized controlled trial safety

摘要:
Background and rationale: Although many therapies have been investigated for intracerebral hemorrhage (ICH), none have succeeded in improving the functional outcomes. Remote ischemic conditioning (RIC) has been proven to promote hematoma resolution and improve neurological outcomes in an ICH model; whether it is safe and feasible in patients with ICH remains unknown. This trial aims to assess the safety, feasibility, and preliminary efficacy of RIC in patients with ICH and to plan for a phase-2 study. Methods: A proof-of-concept, assessor-blinded, pilot open-label randomized controlled trial will be carried out with patients with ICH within 24-48 h of ictus. All participants will be randomly allocated to the intervention group and the control group with a 1:1 ratio (n = 20) and will be treated with standard managements according to the guidelines. Participants allocated to the intervention group will receive RIC once daily for 7 consecutive days. Cranial computed tomography examinations will be performed at baseline, and on days 3, 7, and 14. Neurological outcomes will be assessed at baseline, and on days 1 to 14, 30, and 90. The primary outcome to be tested is safety. Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events. Discussions: This study will be the first proof-of-concept randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of RIC in patients with ICH, results of which will provide parameters for future studies and provide insights into the treatment of ICH.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
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出版当年[2018]版:
Q3 CLINICAL NEUROLOGY Q3 NEUROSCIENCES
最新[2023]版:
Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China, [2]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China, [3]Clinical Stroke Research Unit, Xuanwu Hospital, Capital Medical University, Beijing, China,
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