protocolSection identificationModule nctId: NCT06374667, orgStudyIdInfo id: KY2024-071-02, briefTitle: The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction, acronym: SOLUTION-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: yilong Wang, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, Acute Ischemic, conditions: Blood-Brain Barrier, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Y-3 ICO injection, interventions name: Y-3 intravenous injection, interventions name: Conventional treatment, outcomesModule primaryOutcomes measure: 90-day favorable clinical outcome, secondaryOutcomes measure: Change of infarct volume from baseline to 8-day, secondaryOutcomes measure: Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) ., secondaryOutcomes measure: Patients with symptoms improvement from baseline to 14-day, secondaryOutcomes measure: Rate of decompressive hemicraniectomy, secondaryOutcomes measure: Depression scale scores at 90-day, secondaryOutcomes measure: Proportion of combined adverse events at 90-day, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first affiliated hospital of Wannan Medical College, status: NOT_YET_RECRUITING, city: Wuhu, state: Anhui, country: China, contacts name: Shoucai Zhao, MD, role: CONTACT, contacts name: Zhenbao Li, MD, role: CONTACT, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Yilong Wang, PhD，MD, role: CONTACT, email: yilong538@gmail.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Tangshan Municipal Worker's Hospital, status: NOT_YET_RECRUITING, city: Tangshan, state: Heibei, country: China, contacts name: Jun Hong, MD, role: CONTACT, geoPoint lat: 39.63333, lon: 118.18333, locations facility: Shaanxi Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Wei Hu, MD, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False