[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501214":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":53,"responsibleParty":90,"collaborators":92,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":51,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":51,"enrollmentInfo":110,"targetDuration":51,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":51,"overallStatus":55,"whyStopped":51,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Konkuk University Medical Center","OTHER",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Empirical 1: TXA and Placebo administration","ACTIVE_COMPARATOR","Tranexamic acid administration, regardless of the result of rotational thromboelastometry.\n\nPlacebo administration, at LI60 \\\u003C 85 % or A10\\\u003C 40 mm in EXTEM of rotational thromboelastometry",[13,14],"Drug: TXA administration","Drug: Placebo administration",{"label":16,"type":10,"description":17,"interventionNames":18},"Empirical 2: TXA administration","Tranexamic acid administration, regardless of the result of rotational thromboelastometry.\n\nPlacebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Goal-directed 1: Placebo administration","EXPERIMENTAL","Placebo administration, regardless of the result of rotational thromboelastometry.\n\nTranexamic acid administration at LI60 \\\u003C 85 % or A10 \\\u003C 40 mm in EXTEM of rotational thromboelastometry",[13,14],{"label":25,"type":21,"description":26,"interventionNames":27},"Goal-directed 2: TXA and Placebo administration","Placebo administration, regardless of the result of rotational thromboelastometry.\n\nTranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry",[14],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","TXA administration","Tranexamic acid intravenous administration",[9,16,20],[35],"Tranexamic acid",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo administration","Placebo (normal saline) intravenous administration",[9,20,25],[41],"Placebo (normal saline)",[43],{"name":44,"affiliation":5,"role":45},"Tae-Yop Kim, MD, PhD","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Tae-Yop Kim, MD PhD","CONTACT","+82-10-8811-6942",null,"taeyop@gmail.com",[54,70,81],{"facility":5,"status":55,"city":56,"state":51,"zip":57,"country":58,"countryCode":51,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Seoul","05030","South Korea",{"type":60,"coordinates":61},"Point",[62,63],126.9784,37.566,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":68,"phoneExt":51,"email":69},"Chung-Sik Oh, MD, PhD","+821062771287","ohcsik@daum.net",{"facility":71,"status":55,"city":56,"state":51,"zip":72,"country":58,"countryCode":51,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Samsung Medical Center","06351",{"type":60,"coordinates":74},[62,63],{"lat":63,"lon":62},[77],{"name":78,"role":49,"phone":79,"phoneExt":51,"email":80},"Jung Chan Park, MD","+821089960031","jc83.park@samsung.com",{"facility":82,"status":55,"city":56,"state":51,"zip":51,"country":58,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Asan Medical Center",{"type":60,"coordinates":84},[62,63],{"lat":63,"lon":62},[87],{"name":88,"role":49,"phone":51,"phoneExt":51,"email":89},"Jaesik Nam","jaesik_nam@naver.com",{"type":45,"investigatorFullName":48,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Professor of Anesthesiology",[93,96,99,100],{"name":94,"class":95},"Korea Health Industry Development Institute","OTHER_GOV",{"name":97,"class":98},"Helptrial","UNKNOWN",{"name":82,"class":6},{"name":71,"class":6},"100501214","goal-directed-vs-empirical-tranexamic-acid-administrationin-cardiovascular-surgery-100501214",false,"NCT05806346","Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery","Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration","Inclusion Criteria:\n\n* patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass\n* patients who provide written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* refusal of allogenic blood transfusion\n* taking thrombin\n* history of thromboembolic and familial hypercoagulability disease\n* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)\n* hypersensitive to TXA\n* histroy of convulsion or epilepsy\n* taking hemodialysis\n* history of Heparin-induced thrombocytopenia","ALL","19 Years",{"count":111,"type":112},764,"ESTIMATED","INTERVENTIONAL",[115],"NA","The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.\n\nThe study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.\n\nThe secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.\n\nResearchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.",[118,119,120,121,122],"Heart Diseases","Vascular Diseases","Transfusion Related Complication","Coagulation Disorder, Blood","Fibrinolysis; Hemorrhage","2024-12-15",{"date":125,"type":126},"2024-12-18","ACTUAL",{"date":128,"type":126},"2023-08-01",{"date":130,"type":112},"2025-06-30",{"name":5,"class":6},3]