EClinicalMedicine. 2026 Apr 13;95:103900. doi: 10.1016/j.eclinm.2026.103900. eCollection 2026 May.
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.
PMID:42011250 | PMC:PMC13092074 | DOI:10.1016/j.eclinm.2026.103900