Abstract
RATIONALE: The blood-brain barrier (BBB) largely restricts the efficacy of neuroprotectants, which is an important approach in treating large hemispheric infarction (LHI). In this study, we harnessed intracalvariosseous (ICO) injection to bypass the BBB and facilitate drug delivery. AIM: To compare the efficacy and safety of ICO injection versus intravenous injection in the treatment of acute LHI within 24 hours of disease onset. METHODS AND DESIGN: The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2) is a multicentre, prospective, randomised, open-label, blind endpoint trial. 134 patients with acute LHI from more than six centres will be enrolled and randomised in the trial to receive ICO or intravenous injection of Y-3 in a 1:1 ratio. STUDY OUTCOMES: The primary efficacy outcome is the proportion of patients with a modified Rankin Scale score of 0-3 at 90 days after symptom onset. Primary safety outcomes include infection events related to ICO injection procedures. DISCUSSION: Results from the SOLUTION-2 trial will contribute to the understanding of the efficacy and safety of the Y-3 ICO injection in patients with LHI. TRIAL REGISTRY: The efficacy and safety of Y-3 ICO injection versus intravenous injection in the treatment of acute LHI (SOLUTION-2). URL: https://clinicaltrials.gov/study/NCT06374667?cond=SOLUTION-2&intr=y-3&rank=1. TRIAL REGISTRATION NUMBER: NCT06374667.