[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415226":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":62,"collaborators":65,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":18,"enrollmentInfo":126,"targetDuration":18,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"First Affiliated Hospital of Fujian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"STAPLE group","EXPERIMENTAL","In patients enrolled in the STAPLE group to receive the stereotactic CTA-guided aspiration and drainage, the surgery is performed within 36 h of symptoms onset. Urokinase injection is determined according to the CT scan 6 h after the surgery. Then the optimal dose of urokinase determined in Step A will be given. On the 1st, 3rd, 5th, and 7th day of post-operation, patients will be re-examined using CT. Conventional craniotomy and hematoma evacuation can be performed when cerebral hernia or rebleeding happened.",[13],"Procedure: STAPLE",{"label":15,"type":16,"description":17,"interventionNames":18},"Conservative treatment group","NO_INTERVENTION","Patients in the conservative treatment group are treated routinely in accordance with Guidelines for the Management of Spontaneous Intracerebral Hemorrhage (AHA\u002FASA, 2015) 9. Hematoma evacuation by craniotomy or decompressive hemicraniectomy is considered in deteriorating patients as a life-saving measure.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","STAPLE","Stereotactic aspiration plus urokinase clot irrigation",[9],[26],{"name":27,"affiliation":28,"role":29},"Kang Dezhi, MD.","The first affilicated hospital of Fujian Medical univercity","STUDY_CHAIR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Lin Fuxin, PHD,MD","CONTACT","+86 13552358381","lfxstuy@126.com",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Kang Dezhi, MD","+86 13859099988","kdz999888@163.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Fuzhou","Fujian","China","CN",{"type":48,"coordinates":49},"Point",[50,51],119.30611,26.06139,{"lat":51,"lon":50},[54,57,60],{"name":55,"role":33,"phone":34,"phoneExt":18,"email":56},"Lin Fuxin, MD","lfxstudy@126.com",{"name":58,"role":59,"phone":18,"phoneExt":18,"email":18},"Kang Dezhi, PHD,MD","PRINCIPAL_INVESTIGATOR",{"name":55,"role":61,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":59,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"De-zhi Kang","Doctor",[66,69,71,73,76,78,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114],{"name":67,"class":68},"Department of Science and Technology of Fujian province","UNKNOWN",{"name":70,"class":6},"Longyan City First Hospital",{"name":72,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":74,"class":75},"Shanxi Provincial People's Hospital","OTHER_GOV",{"name":77,"class":6},"Tangshan Gongren Hospital",{"name":79,"class":6},"Lanzhou University Second Hospital",{"name":81,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":83,"class":6},"The Second Hospital of Shandong University",{"name":85,"class":68},"Shishi General Hospital",{"name":87,"class":68},"Wuping County Hospital",{"name":89,"class":68},"Fuqing Municipal Hospital",{"name":91,"class":6},"Qingyuan People's Hospital",{"name":93,"class":68},"Jinjiang Municipal Hospital",{"name":95,"class":68},"Anxi County Hospital",{"name":97,"class":68},"Nanan Hospital",{"name":99,"class":68},"MinDong Hospital of Ningde City",{"name":101,"class":68},"Affiliated Hospital of Putian University",{"name":103,"class":68},"Lianjiang County Hospital",{"name":105,"class":68},"Shunchang County Hospital",{"name":107,"class":6},"Yulin No.2 Hospital",{"name":109,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":111,"class":6},"Second Affiliated Hospital of Xiamen Medical College",{"name":113,"class":6},"Zhangzhou Municipal Hospital of Fujian Province",{"name":115,"class":68},"Longyan People's Hospital of Fujian Province","100415226","safety-and-efficacy-of-stereotactic-aspiration-plus-urokinase-in-deep-intracerebral-hemorrhage-evacuation-100415226",false,"NCT04686877","Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation","Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation: a Multicentral Randomized, Controlled, Open-label, Trial","STAPLE-dICH","Inclusion criteria:\n\n1. aged 40 years or older;\n2. the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;\n3. patients with a spontaneous ICH in the deep brain parenchyma (≥1 cm from the cortical surface); with hematoma volume more than 25 ml (measured with the ABC\u002F2 method); without hydrocephalus caused by intraventricular hemorrhage; without cerebral herniation and the benefit of surgical treatment was unknown;\n4. The Glasgow Coma Scale (GCS) ranged from 9 to 15;\n5. patients with motor deficits;\n6. The modified Rankin Score (mRS) ranged from 0 to1 before onset.\n\nExclusion Criteria:\n\n1. ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;\n2. patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;\n3. patients had severe coagulation disorders with INR ≥ 1.5;\n4. patients had severe underlying diseases, which may affect the outcomes;\n5. pregnant and lactating patients;\n6. patients refused to sign the informed consent and receive follow-up.","ALL","40 Years",{"count":127,"type":128},400,"ESTIMATED","INTERVENTIONAL",[131],"NA","This is a nationwide, multicenter, open-label, randomized controlled trial of early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH). The study consists of 2 steps: the first step is to conduct a dose climbing test to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration; the second step is to validate whether stereotactic aspiration plus urokinase irrigation (the optimal dose determined in step one) is superior to conservative treatment in improving long-term outcomes (1 year) in early (within 24h) dICH patients.",[134],"Treatment of Spontaneous Intracerebral Hemorrhage",[136,137,138,139,140],"Deep-Seated Spontaneous Intracerebral Hemorrhage","Stereotactic Aspiration","Urokinase Irrigation","Randomized Controlled Trial","Long-term outcome","2025-02-08",{"date":143,"type":144},"2025-02-12","ACTUAL",{"date":146,"type":144},"2021-01-31",{"date":148,"type":128},"2025-09-30",{"name":5,"class":6},1]