[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604987":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":135,"collaborators":137,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":27,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":173,"whyStopped":27,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"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",[55,71,84,97,109,122],{"facility":56,"status":27,"city":57,"state":58,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","China","CN",{"type":62,"coordinates":63},"Point",[64,65],117.28083,31.86389,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":70,"phoneExt":27,"email":27},"Qian Gong","86 + 18226616000",{"facility":72,"status":27,"city":73,"state":74,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Fujian Provincial Hospital","Fuzhou","Fujian",{"type":62,"coordinates":76},[77,78],119.30611,26.06139,{"lat":78,"lon":77},[81],{"name":82,"role":47,"phone":83,"phoneExt":27,"email":27},"Han Chen","86 + 18695770932",{"facility":85,"status":27,"city":86,"state":87,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)","Guangzhou","Guangdong",{"type":62,"coordinates":89},[90,91],113.25,23.11667,{"lat":91,"lon":90},[94],{"name":95,"role":47,"phone":96,"phoneExt":27,"email":27},"Liming Lei","86 + 18688906579",{"facility":98,"status":27,"city":99,"state":87,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The University of Hong Kong - Shenzhen Hospital","Shenzhen",{"type":62,"coordinates":101},[102,103],114.0683,22.54554,{"lat":103,"lon":102},[106],{"name":107,"role":47,"phone":108,"phoneExt":27,"email":27},"Peijun Li","86 + 18002093166",{"facility":110,"status":27,"city":111,"state":112,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"The First Affiliated Hospital of Xi'an Jiao Tong University","Xi'an","Shaanxi",{"type":62,"coordinates":114},[115,116],108.92861,34.25833,{"lat":116,"lon":115},[119],{"name":120,"role":47,"phone":121,"phoneExt":27,"email":27},"Tao Shi","86 + 13891881699",{"facility":123,"status":27,"city":124,"state":125,"zip":27,"country":59,"countryCode":60,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Changhai Hospital of Shanghai","Shanghai","Shanghai Municipality",{"type":62,"coordinates":127},[128,129],121.45806,31.22222,{"lat":129,"lon":128},[132],{"name":133,"role":47,"phone":134,"phoneExt":27,"email":27},"Bailing Li","86 + 13601973040",{"type":136,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[138,139,140,142,144,146],{"name":56,"class":6},{"name":72,"class":6},{"name":141,"class":6},"The University of Hong Kong-Shenzhen Hospital",{"name":143,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":145,"class":6},"Guangdong Provincial People's Hospital",{"name":147,"class":6},"Changhai Hospital","100604987","phase-4-sivelestat-treatment-for-postoperative-organ-protection-in-type-a-aortic-dissection-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":160,"type":161},236,"ESTIMATED","INTERVENTIONAL",[164],"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",[167,168],"Type A Aortic Dissection","Organ Failure, Multiple",[167,170,171,172],"SOFA","Sivelestat Sodium","Multiple Organ Failure","NOT_YET_RECRUITING","2025-08-27",{"date":176,"type":177},"2025-09-05","ACTUAL",{"date":179,"type":161},"2025-09-01",{"date":181,"type":161},"2028-09-30",{"name":5,"class":6},6]