Remote ischaemic conditioning in patients with supratentorial intracerebral haemorrhage (RICH-2): a multicentre, randomised, sham-controlled phase 3 trial in China
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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 in 19 (8.3%) of 229 patients in the RIC group and 20 (8.7%) in the sham group, and no deaths were attributed to the RIC intervention. Interpretation: In patients with acute supratentorial ICH managed without surgery, RIC did not improve 90-day functional outcomes. Further research should evaluate its efficacy in selected populations using optimised protocols. Funding: National Natural Science Foundation of China; Beijing Natural Science Foundation; National Key R&D Program of China.
Source: EClinicalMedicine
Authors: 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, Jiangtao 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
Institutions: Capital Medical University, University of Cambridge, Xuan Wu Hospital of the Capital Medical University, Zhejiang University, Soochow University, The First People's Hospital of Changzhou, Tianjin Huanhu Hospital, Jiaxing University, Shengli Oilfield Central Hospital, People’s Hospital of Rizhao, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing Institute for Brain Disorders, Augusta University, Fudan University, Royal Prince Alfred Hospital, UNSW Sydney, The George Institute for Global Health
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,780
OpenAlex ID: W7154125514