[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639340":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":49,"locations":59,"responsibleParty":76,"collaborators":54,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":54,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":54,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":54,"overallStatus":61,"whyStopped":54,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Poznan University of Medical Sciences","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"TXA Bolus + Infusion","EXPERIMENTAL","Tranexamic acid administered intravenously as a 15 mg\u002Fkg bolus after induction of anesthesia, followed by continuous infusion at 1 mg\u002Fkg\u002Fh until the end of surgery. Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.",[13],"Drug: Tranexamic Acid Bolus Plus Infusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","0.9% sodium chloride (saline) administered intravenously in the same volumes and timing as the active comparator groups (bolus and infusion). All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.",[19],"Drug: Sodium Chloride 0.9% Inj",{"label":21,"type":10,"description":22,"interventionNames":23},"TXA Bolus Only","Tranexamic acid administered intravenously as two bolus doses: 10 mg\u002Fkg after induction of anesthesia and 10 mg\u002Fkg 120 minutes after surgical incision or at the beginning of rod placement (whichever occurs first). Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.",[24],"Drug: Tranexamic Acid Bolus Only",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Tranexamic Acid Bolus Plus Infusion","Tranexamic acid administered intravenously as a 15 mg\u002Fkg bolus after induction of anesthesia, followed by continuous infusion at 1 mg\u002Fkg\u002Fh until the end of surgery.",[9],[32],"TXA bolus plus infusion; Tranexamic acid; TXA; Cyklokapron; Exacyl",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Sodium Chloride 0.9% Inj","Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.",[15],[38],"Normal Saline; NaCl 0.9%",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Tranexamic Acid Bolus Only","Tranexamic acid administered intravenously as two bolus doses: 10 mg\u002Fkg after induction of anesthesia and 10 mg\u002Fkg 120 minutes after surgical incision or at the beginning of rod placement, whichever occurs first.",[21],[44],"TXA bolus only; Tranexamic acid; TXA; Cyklokapron; Exacyl",[46],{"name":47,"affiliation":5,"role":48},"Małgorzata Reysner, MD PhD","STUDY_CHAIR",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Malgorzata Reysner, MD PhD","CONTACT","+48 61 831-01-22",null,"mreysner@ump.edu.pl",{"name":57,"role":52,"phone":54,"phoneExt":54,"email":58},"Piotr Janusz, MD PhD","pjanusz@um.edu.pl",[60],{"facility":5,"status":61,"city":62,"state":54,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Poznan","62-701","Poland","PL",{"type":67,"coordinates":68},"Point",[69,70],16.92993,52.40692,{"lat":70,"lon":69},[73],{"name":74,"role":52,"phone":75,"phoneExt":54,"email":55},"Malgorzata Reysner, M.D. Ph.D.","+48 61 873 83 03",{"type":77,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100639340","tranexamic-acid-in-pediatric-idiopathic-scoliosis-surgery-100639340",false,"NCT07581457","Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery","Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind Trial","Inclusion Criteria:\n\n* Age 10 to 18 years\n* Diagnosis of idiopathic scoliosis requiring surgical correction (posterior spinal fusion)\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Written informed consent from parents or legal guardians and assent from the child\n\nExclusion Criteria:\n\n* Congenital or acquired coagulopathy\n* History of thromboembolic disease\n* History of seizures or epilepsy\n* Known hypersensitivity to tranexamic acid\n* Renal insufficiency (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m²)\n* Cardiac arrhythmias or cardiovascular disease requiring antiplatelet or anticoagulant therapy","ALL","10 Years","18 Years",{"count":89,"type":90},90,"ESTIMATED","INTERVENTIONAL",[93],"NA","This study will evaluate whether tranexamic acid (TXA), a medication used to reduce bleeding, is effective and safe in children undergoing surgery for idiopathic scoliosis. Significant blood loss is common during this type of surgery and often requires blood transfusions.\n\nParticipants will be randomly assigned to one of three groups: (1) TXA given as an intravenous bolus followed by continuous infusion, (2) TXA given as two intravenous bolus doses, or (3) placebo (saline). Neither the patients nor the medical team will know which treatment is given.\n\nThe main goal is to compare how much blood is lost during and after surgery and whether TXA reduces the need for blood transfusions. The study will also assess safety, including the risk of side effects such as seizures or blood clots.\n\nPatients will be followed for up to 30 days after surgery.",[96,97],"Scoliosis Idiopathic","Scoliosis; Adolescence","2026-06-29",{"date":100,"type":101},"2026-07-01","ACTUAL",{"date":103,"type":90},"2026-06-01",{"date":105,"type":90},"2027-06-30",{"name":5,"class":6},1]