[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649838":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":27,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":95,"whyStopped":27,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Clinique Saint-Luc","NETWORK",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Tranexamic Acid","EXPERIMENTAL","Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.",[13,14],"Drug: Oral tranexamic acid","Drug: Intravenous placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Intravenous Tranexamic Acid","ACTIVE_COMPARATOR","Participants receive four matching oral placebo tablets approximately 2 hours before surgical incision, together with 1 g of intravenous tranexamic acid administered at induction or incision according to the study protocol.",[20],"Drug: Exacyl®",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Oral tranexamic acid","Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Exacyl®","Tranexamic acid, 1 g intravenously, diluted in 0.9% sodium chloride to a total volume of 50 mL and administered at induction or incision according to the study protocol.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Intravenous placebo","Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.",[9],[37],{"name":38,"affiliation":39,"role":40},"Benjamin Javillier, MD","Clinique Saint-Luc Bouge","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","081 20 91 55","+32","benjamin.javillier@slbo.be",[48],{"facility":5,"status":27,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Bouge","Namur","5004","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],4.89218,50.47193,{"lat":58,"lon":57},[61],{"name":38,"role":43,"phone":62,"phoneExt":45,"email":46},"081209155",{"type":40,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Benjamin JAVILLIER","Principal Investigator","100649838","phase-4-oral-versus-intravenous-tranexamic-acid-in-off-pump-coronary-artery-bypass-surgery-100649838",false,"NCT07740330","Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery","Oral Versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomized Double-Blind Non-Inferiority Trial","TRANSCAB","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Elective isolated coronary artery bypass grafting planned without cardiopulmonary bypass, including off-pump coronary artery bypass through sternotomy or minimally invasive\u002Fdirect or totally endoscopic coronary artery bypass surgery. Conversion to cardiopulmonary bypass is permitted if clinically required.\n3. Perioperative tranexamic acid planned as part of routine care, with the participant eligible for both oral and intravenous administration according to the applicable product information and local policy.\n4. Written informed consent obtained before randomization.\n5. Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.\n6. Available for in-hospital follow-up and Day 30 assessment.\n\nExclusion Criteria:\n\n1. Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.\n2. Inability to provide informed consent or comply with the required follow-up.\n3. Hypersensitivity to tranexamic acid or any excipient of the study products.\n4. Contraindication or clinically relevant precaution to tranexamic acid according to the applicable product information, including:\n\n   * active arterial or venous thromboembolic disease or active intravascular clotting;\n   * history of subarachnoid hemorrhage;\n   * acquired defective color vision;\n   * clinically relevant seizure disorder or previous tranexamic-acid-associated seizure;\n   * disseminated intravascular coagulation without predominant hyperfibrinolysis;\n   * active upper urinary tract hematuria with a risk of ureteric obstruction.\n5. Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² or dialysis.\n6. Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.\n7. Pregnancy or breastfeeding.\n8. Participation in another interventional clinical trial that could interfere with study outcomes or safety.\n9. Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.\n10. Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.\n11. Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.","ALL","18 Years",{"count":77,"type":78},160,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established.\n\nTRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction.\n\nThe primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.",[84,85],"Coronary Artery Disease","Perioperative Bleeding",[87,88,89,90,91,92,93,94],"Tranexamic Acid","Off-Pump Coronary Artery Bypass Grafting","OPCAB","Oral Administration","Intravenous Administration","Postoperative Blood Loss","Cardiac Surgery","Non-Inferiority Trial","NOT_YET_RECRUITING","2026-07-30",{"date":98,"type":99},"2026-07-31","ACTUAL",{"date":101,"type":78},"2026-10",{"date":103,"type":78},"2028-07",{"name":5,"class":6},1]