机构:[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China,神经科系统神经内科首都医科大学宣武医院[2]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China,科技平台低氧适应转化医学北京市重点实验室首都医科大学宣武医院[3]Clinical Stroke Research Unit, Xuanwu Hospital, Capital Medical University, Beijing, China,首都医科大学宣武医院神经内科[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神经科系统神经外科首都医科大学宣武医院
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.
基金:
Beijing Hundred Thousand and Ten Thousand Talent Project [2019A36]; National Key R&D Program of China [2017YFC1308400]; Science and Technology Development Project of Beijing Municipal Health Commission; Nature Science Foundation of ChinaNational Natural Science Foundation of China [81573867, 81971114, 8181313]
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,
通讯作者:
推荐引用方式(GB/T 7714):
Zhao Wenbo,Jiang Fang,Li Sijie,et al.Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial[J].FRONTIERS IN NEUROLOGY.2020,11:doi:10.3389/fneur.2020.00313.
APA:
Zhao, Wenbo,Jiang, Fang,Li, Sijie,Wu, Chuanjie,Gu, Fei...&Ji, Xunming.(2020).Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial.FRONTIERS IN NEUROLOGY,11,
MLA:
Zhao, Wenbo,et al."Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial".FRONTIERS IN NEUROLOGY 11.(2020)