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Remote ischaemic conditioning in patients with supratentorial intracerebral haemorrhage (RICH-2): a multicentre, randomised, sham-controlled phase 3 trial in China

作者:Wenbo Zhao, Jing Wang, Xuebin Yu, Guang Wu, Song Yang, Da Lu, Xinjing Gao, Yuping He, Lijian Niu, Haihang Zhou, Caixia Xuan, Na Li, Mengfei Zhong, Lei Zhang, Qinglin Dong, Xiaokun Geng, Qingfeng Ma, Haiqing Song, Yunjian Yin, Lan Liu, David C. Hess, Craig S. Anderson, Sijie Li, Xunming Ji, Xunming Ji, Xunming Ji, Xunming Ji, Zhiying Zhao, Jianli Niu, Lin Zhao, Song Yang, Na Li, Yanbo Cheng, Xuebin Yu, Yuping He, Haihang Zhou, Mengfei Zhong, Ming Wei, Xinjing Gao, Guang Wu, Jiangtao Zhang, Chaixia Xuan, Qingling Dong, Junzhao Sun, Jianguo Wang, Xiaokun Geng · 发表于:EClinicalMedicine · 年份:2026 · DOI:10.1016/j.eclinm.2026.103900 · 研究领域:Intracerebral and Subarachnoid Hemorrhage Research、Acute Ischemic Stroke Management、Intracranial Aneurysms: Treatment and Complications

Background: Haematoma clearance is a key therapeutic target in intracerebral haemorrhage (ICH). Remote ischaemic conditioning (RIC) has shown potential to accelerate haematoma resolution in preclinical and early-phase clinical studies. We evaluated whether RIC improves functional outcomes in patients with acute supratentorial ICH not requiring surgical intervention. Methods: In this randomised, sham-controlled, outcome-blinded trial at 20 centres in China, adults (aged 18-80 years) with imaging-confirmed supratentorial ICH (volume 10-30 mL, National Institutes of Health Stroke Scale score 6-20, GCS >8) and no surgical indication were randomly assigned (1:1) to receive RIC or sham intervention for 7 days after randomisation, alongside standard medical management. RIC was initiated 24-48 h after onset using an upper-limb cuff inflated to 200 mmHg (sham: 30 mmHg) for five daily cycles of 5-min inflation/deflation. The primary outcome was an mRS score of 0-2 at 90 days (favourable outcome) in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT04657133. Findings: Between April 22, 2021, and April 30, 2024, 458 patients were enrolled (median age 58 years [interquartile range 51-68], female 29.3%). Favourable outcome was achieved in 156 (68.1%) of 229 patients in the RIC group and 163 (71.2%) of 229 in the sham group at 90 days (adjusted risk ratio 0.97, 95% confidence interval 0.87-1.08; p = 0.61). Serious adverse events within 180 days occurred...