At a glance
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NCT06374667N/ARecruitingMonitorUpdated 17mo ago · Completion was 3mo agoThe Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction（SOLUTION-2）
In Brief
A clinical study evaluating Y-3 ICO injection, Y-3 intravenous injection, and 1 other intervention for Stroke, Acute Ischemic and Blood-Brain Barrier. Currently recruiting, targeting 134 participants across 6 sites.
Signals
Detailed Summary
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
Study Details
Timeline
Interventions
Patients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days.
Patients included will be given Y-3 intravenous injection for 7 consecutive days.
standard treatment and management according to related guidelines during the entire treatment period