EClinicalMedicine · 2026
Remote ischaemic conditioning in patients with supratentorial intracerebral haemorrhage (RICH-2): a multicentre, randomised, sham-controlled phase 3 trial in China.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zhao Wenbo, Wang Jing, Yu Xuebin, Wu Guang, Yang Song, Lu Da, Gao Xinjing, He Yuping, Niu Lijian, Zhou Haihang, Xuan Caixia, Li Na, Zhong Mengfei, Zhang Jiangtao, Dong Qinglin, Geng Xiaokun, Ma Qingfeng, Song Haiqing, Yin Yunjian, Liu Lan, Hess David C, Anderson Craig S, Li Sijie, Ji Xunming, RICH-2 Investigators
Аннотация
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.
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.