[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547904":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":75,"collaborators":78,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":41,"enrollmentInfo":95,"targetDuration":41,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":41,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Martin-Luther-Universität Halle-Wittenberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamic acid","EXPERIMENTAL","Intravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg \u002F hour until skin closure)",[13],"Drug: Tranexamic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Intravenous administration of placebo (normal saline), 50 ml bolus 10 minutes prior to skin incision followed by continuous infusion of 6.25 ml \u002F hour until skin closure.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tranexamic Acid","Intravenous administration",[9],[27],"Tranexamsäure Carinopharm 100mg\u002Fml",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],[31],"Isotone Kochsalz-Lösung 0,9% Infusionslösung",[33],{"name":34,"affiliation":35,"role":36},"Ulrich Ronellenfitsch, MD","Medical Faculty of the Martin Luther University Halle-Wittenberg","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+493455572327",null,"ulrich.ronellenfitsch@uk-halle.de",[44,63],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Hospital Carl Gustav Carus Dresden","RECRUITING","Dresden","Saxony","01307","Germany","DE",{"type":53,"coordinates":54},"Point",[55,56],13.73832,51.05089,{"lat":56,"lon":55},[59],{"name":60,"role":39,"phone":61,"phoneExt":41,"email":62},"Olga Radulova-Mauersberger, MD","+49 351 458 19543","olga.radulova-mauersberger@ukdd.de",{"facility":64,"status":46,"city":65,"state":41,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery","Halle","06120",{"type":53,"coordinates":68},[69,70],11.97947,51.48158,{"lat":70,"lon":69},[73],{"name":34,"role":39,"phone":74,"phoneExt":41,"email":42},"+49 345 557 2327",{"type":76,"investigatorFullName":34,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Professor of Evidence-based Abdominal Surgical Oncology",[79,82],{"name":80,"class":81},"German Federal Ministry of Education and Research","OTHER_GOV",{"name":83,"class":84},"Coordinating Centre for Clinical Trials Halle","UNKNOWN","100547904","phase-3-tranexamic-acid-for-reduction-of-transfusion-in-abdominal-surgery-100547904",false,"NCT06414031","Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery","Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial","TATRA","Inclusion Criteria:\n\n1. Age 18 years or above\n2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy\n3. Adequate renal function with serum creatinine \\\u003C250 µmol\u002FL (2.82 mg\u002FdL)\n4. Written informed consent obtained before randomization\n5. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \\\u003C1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).\n\nExclusion Criteria:\n\n1. Severe anaemia, defined as a haemoglobin concentration \\\u003C8 g\u002FdL (\\\u003C5 mmol\u002FL) or anaemia with haemoglobin concentration ≥8 to \\\u003C10 g\u002FdL (≥5,0 to \\\u003C6,2 mmol\u002Fl) and one or several of the following symptoms suggesting hypoxemia:\n\n   * Clinical signs of tachycardia, e.g., resting heart rate \\>100 beats\u002Fminute, palpitation etc.\n   * Clinical signs of hypotension, e.g., resting systolic blood pressure \\\u003C100 mmHg, orthostatic dysregulation etc.\n   * Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \\>20 breaths\u002Fmin.\n2. Thrombocytopenia with platelets \\\u003C60 x 109 \u002FL\n3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)\n4. A priori refusal of blood transfusions\n5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation\n6. Allergy \u002F hypersensitivity to tranexamic acid\n7. Recent (\\\u003C30 days) thromboembolic event\n8. History of medically confirmed convulsions\n9. In female subjects: pregnancy or lactation","ALL","18 Years",{"count":96,"type":97},850,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting.\n\nThe main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery?\n\nParticipants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.",[103,104,105],"Surgical Blood Loss","Transfusion-dependent Anemia","Abdomen Disease","2026-04-28",{"date":108,"type":109},"2026-04-29","ACTUAL",{"date":111,"type":109},"2024-06-17",{"date":113,"type":97},"2026-11-30",{"name":34,"class":6},2]