[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"etamsylate","EXPERIMENTAL","Etamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.",[13],"Drug: etamsylate",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30],{"name":31,"affiliation":32,"role":33},"Yi Luo","The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","86-13666609126","luoyijr@zju.edu.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Luxin Yang","86-13588756650","yangluxin2016@163.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The First Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":52,"coordinates":53},"Point",[54,55],120.16142,30.29365,{"lat":55,"lon":54},[58,60],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":59},"luoyijr@zju.edu.cn",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"type":33,"investigatorFullName":31,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor","100626967","phase-3-comparison-of-etamsylate-versus-placebo-to-prevent-bleeding-in-hsct-100626967",false,"NCT07442513","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive), regardless of gender;\n2. Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation;\n3. Expected platelet count ≤ 10 x 10⁹\u002FL persisting for 5 days or more;\n4. Normal coagulation function;\n5. Adequate organ function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the Upper Limit of Normal (ULN), Total Bilirubin ≤ 2 x ULN; Serum Creatinine ≤ 2 x ULN; Creatinine Clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Echocardiography (ECHO);\n6. Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia confirmed according to WHO diagnostic criteria;\n2. Pregnant or breastfeeding women, and women of childbearing potential unwilling to use effective contraception;\n3. Presence of active bleeding or infection;\n4. History of diagnosed primary immune thrombocytopenia or hemolytic uremic syndrome;\n5. Patients with known hereditary or acquired hemorrhagic disorders;\n6. Patients receiving anticoagulant or antiplatelet therapy;\n7. Patients with severe cardiac insufficiency (left ventricular ejection fraction \\[EF\\] \\\u003C 60%); or severe arrhythmias: history of clinically significant QTc prolongation (male \\> 450 ms; female \\> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block; myocardial infarction within 1 year prior to enrollment; or symptomatic coronary artery disease requiring medication; patients with severe liver impairment (liver function indices \\[ALT, TBIL\\] \\> 3 times the upper limit of normal \\[ULN\\]);\n8. Patients with severe pulmonary insufficiency (obstructive and\u002For restrictive ventilatory defects);\n9. Patients with severe renal insufficiency (renal function index \\[Cr\\] \\> 2 times ULN); or 24-hour urinary creatinine clearance rate (Ccr) \\\u003C 50 ml\u002Fmin;\n10. Patients with mental disorders or other conditions preventing provision of informed consent and compliance with study treatment and procedural requirements;\n11. Other reasons deemed by the investigator to make the patient ineligible for inclusion.","ALL","18 Years","70 Years",{"count":74,"type":75},404,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation.",[81,82],"Hematopoietic Stem Cell Transplantation","Thrombocytopenia",[9,84,85,86],"Hematopoietic Stem Cell Transplantation recipients","thrombocytopenia","bleeding events","2026-02-25",{"date":89,"type":90},"2026-03-02","ACTUAL",{"date":92,"type":90},"2025-12-16",{"date":94,"type":75},"2027-10-31",{"name":5,"class":6},1]