Zhao Wenbo, Jiang Fang, Li Sijie, Wu Chuanjie, Gu Fei, Zhang Quanzhong, Gao Xinjing, Gao Zongen, Song Haiqing, Wang Yuping, Ji Xunming
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.
Front Neurol. 2020 Apr 28;11:313. doi: 10.3389/fneur.2020.00313. eCollection 2020.
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. 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 ( = 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. 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. Clinicaltrials.gov, identifier: NCT03930940.
尽管针对脑出血（ICH）已经研究了多种治疗方法，但均未成功改善功能结局。远程缺血预处理（RIC）已被证明可促进ICH模型中的血肿吸收并改善神经功能结局；其在ICH患者中是否安全可行仍不清楚。本试验旨在评估RIC在ICH患者中的安全性、可行性和初步疗效，并为2期研究制定计划。将对发病24 - 48小时内的ICH患者进行一项概念验证、评估者盲法、先导开放标签随机对照试验。所有参与者将按1:1比例（每组n = 20）随机分配至干预组和对照组，并根据指南接受标准管理。分配至干预组的参与者将连续7天每天接受一次RIC治疗。将在基线、第3天、第7天和第14天进行头颅计算机断层扫描检查。将在基线、第1至14天、第30天和第90天评估神经功能结局。要测试的主要结局是安全性。次要测试结局包括血肿和血肿周围水肿体积的变化、血肿扩大的发生率、功能结局以及不良事件的发生频率。本研究将是第一项确定RIC在ICH患者中的安全性、可行性和初步疗效的概念验证随机对照试验，其结果将为未来研究提供参数，并为ICH的治疗提供见解。Clinicaltrials.gov标识符：NCT03930940。
