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

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.

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Publication Details

Journal
EClinicalMedicine
Published
2026-04-13
DOI
https://doi.org/10.1016/j.eclinm.2026.103900
Primary Topic
Intracerebral and Subarachnoid Hemorrhage Research
Type
article
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0.00

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article

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

Craig S. Anderson, Lei Zhang, Yunjian Yin, Qingfeng Ma et al.
EClinicalMedicine
Intracerebral and Subarachnoid Hemorrhage Research
article

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

Craig S. Anderson, Lei Zhang, Yunjian Yin, Qingfeng Ma, Song Yang, Lijian Niu, David Charles Hess, Xinjing Gao, Xuebin Yu, Qinglin Dong, Wenbo Zhao, Mengfei Zhong, Jianli Niu, Guang Wu, Sijie Li, Haiqing Song, Zhiying Zhao, Qingling Dong, Lan Liu, Yuping He, Na Li, Xunming Ji, Junzhao Sun, Lin Zhao, Yanbo Cheng, Chaixia Xuan, Jing Wang, Caixia Xuan, Ming Wei, Jianguo Wang, Da Lu
article en

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.

EClinicalMedicineVol. 95
Hengshui University (CN), Capital Medical University (CN), University of Cambridge (GB), Augusta University (US), Royal Prince Alfred Hospital (AU), UNSW Sydney (AU), Soochow University (CN), Beijing Geriatric Hospital (CN), Jiaxing University (CN), Taizhou Second People's Hospital (CN), People’s Hospital of Rizhao (CN), Tianjin Huanhu Hospital (CN), Affiliated Hospital of Chengde Medical College (CN), The George Institute for Global Health (AU), Chengde Medical University (CN), Beijing Luhe Hospital Affiliated to Capital Medical University (CN), Nanyang Institute of Technology (CN), Chinese Institute for Brain Research (CN), Zhejiang Hospital (CN), Shengli Oilfield Central Hospital (CN), First Affiliated Hospital of Soochow University (CN), Shaoxing People's Hospital (CN), Beijing Fengtai Hospital (CN), Shanghai Center for Brain Science and Brain-Inspired Technology (CN)
Bayer, Royal Perth Hospital Medical Research Foundation, National Natural Science Foundation of China, Capital Medical University, Ministry of Science and Technology of the People's Republic of China, Beijing Municipal Education Commission, Natural Science Foundation of Beijing Municipality, Beijing Municipal Science and Technology Commission, Beijing Municipal Bureau of Finance, National Institutes of Health, National Health and Medical Research Council, Beijing Nova Program, Key Technologies Research and Development Program
Openalex Percentile: Top 15%
Intracerebral and Subarachnoid Hemorrhage Research
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