[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604987":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":134,"collaborators":136,"id":147,"slug":27,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":27,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":171,"whyStopped":27,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sivelestat group","EXPERIMENTAL","Drug: Sivelestat Sodium. Procedure: Conventional Treatment",[13,14],"Procedure: Conventional treatment","Drug: Sivelestat sodium",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","PLACEBO_COMPARATOR","Drug: Placebo. Procedure: Conventional Treatment",[13,20],"Drug: Placebo",[22,28,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Conventional treatment","Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.",[16,9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Sivelestat sodium","The daily dose (4.8 mg\u002Fkg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL\u002Fh (equivalent to 0.2 mg\u002Fkg\u002Fh) for 72 consecutive hours.",[9],[34],"Siv",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"Placebo","An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL\u002Fh for 72 consecutive hours.",[16],[40],{"name":41,"affiliation":42,"role":43},"Zhe Luo","Fudan University","STUDY_CHAIR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Guowei Tu","CONTACT","86 + 13501996995","tu.guowei@zs-hospital.sh.cn",{"name":51,"role":47,"phone":52,"phoneExt":27,"email":53},"Chenxu Lin","86 + 18016402139","chenxu_lin@163.com",[55,70,83,96,108,121],{"facility":56,"status":27,"city":57,"state":58,"zip":27,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","China",{"type":61,"coordinates":62},"Point",[63,64],117.28083,31.86389,{"lat":64,"lon":63},[67],{"name":68,"role":47,"phone":69,"phoneExt":27,"email":27},"Qian Gong","86 + 18226616000",{"facility":71,"status":27,"city":72,"state":73,"zip":27,"country":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Fujian Provincial Hospital","Fuzhou","Fujian",{"type":61,"coordinates":75},[76,77],119.30611,26.06139,{"lat":77,"lon":76},[80],{"name":81,"role":47,"phone":82,"phoneExt":27,"email":27},"Han Chen","86 + 18695770932",{"facility":84,"status":27,"city":85,"state":86,"zip":27,"country":59,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)","Guangzhou","Guangdong",{"type":61,"coordinates":88},[89,90],113.25,23.11667,{"lat":90,"lon":89},[93],{"name":94,"role":47,"phone":95,"phoneExt":27,"email":27},"Liming Lei","86 + 18688906579",{"facility":97,"status":27,"city":98,"state":86,"zip":27,"country":59,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The University of Hong Kong - Shenzhen Hospital","Shenzhen",{"type":61,"coordinates":100},[101,102],114.0683,22.54554,{"lat":102,"lon":101},[105],{"name":106,"role":47,"phone":107,"phoneExt":27,"email":27},"Peijun Li","86 + 18002093166",{"facility":109,"status":27,"city":110,"state":111,"zip":27,"country":59,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"The First Affiliated Hospital of Xi'an Jiao Tong University","Xi'an","Shaanxi",{"type":61,"coordinates":113},[114,115],108.92861,34.25833,{"lat":115,"lon":114},[118],{"name":119,"role":47,"phone":120,"phoneExt":27,"email":27},"Tao Shi","86 + 13891881699",{"facility":122,"status":27,"city":123,"state":124,"zip":27,"country":59,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Changhai Hospital of Shanghai","Shanghai","Shanghai Municipality",{"type":61,"coordinates":126},[127,128],121.45806,31.22222,{"lat":128,"lon":127},[131],{"name":132,"role":47,"phone":133,"phoneExt":27,"email":27},"Bailing Li","86 + 13601973040",{"type":135,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[137,138,139,141,143,145],{"name":56,"class":6},{"name":71,"class":6},{"name":140,"class":6},"The University of Hong Kong-Shenzhen Hospital",{"name":142,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":144,"class":6},"Guangdong Provincial People's Hospital",{"name":146,"class":6},"Changhai Hospital","100604987",false,"NCT07156656","Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection","Assessment of the Efficacy of Sivelestat Sodium Treatment in Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection (STOP): a Multicenter, Double-blind RCT","STOP","Inclusion Criteria:\n\n1. Age 18-75 years inclusive.\n2. Written informed consent obtained before participation.\n3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.\n\nExclusion Criteria:\n\n1. Life expectancy ≤ 48 hours.\n2. Pregnant or lactation.\n3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.\n4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.\n5. Confirmed COPD or asthma.\n6. Immunosuppression: long-term or \\> 2 weeks continuous systemic corticosteroids.\n7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).\n8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.","ALL","18 Years","75 Years",{"count":158,"type":159},236,"ESTIMATED","INTERVENTIONAL",[162],"PHASE4","The goal of this multicenter, double-blind, randomized controlled trial is to learn if sivelestat sodium (Siv) can protect the organ function in patients suffered operation for acute type A aortic dissection. The main questions it aims to answer are:\n\n* Can the 3-day-treatment of Siv enlarge the Day-0-to-Day-5 drop in the organ-health score (SOFA score)?\n* Can this treatment significantly shrink the area under the SOFA curve from first dose to Day 5?\n* Can this treatment significantly improve the end of patients in 28 days (clinical outcomes)? Researchers will compare drug Siv to a placebo (a look-alike substance that contains no drug) to see if drug Siv works.\n\nParticipants will:\n\n* Take drug Siv or the placebo through vein continuously for 72 hours\n* Receiving regular intensive care in ICU after the operation",[165,166],"Type A Aortic Dissection","Organ Failure, Multiple",[165,168,169,170],"SOFA","Sivelestat Sodium","Multiple Organ Failure","NOT_YET_RECRUITING","2025-08-27",{"date":174,"type":175},"2025-09-05","ACTUAL",{"date":177,"type":159},"2025-09-01",{"date":179,"type":159},"2028-09-30",{"name":5,"class":6},6]