[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563930":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":45,"centralContacts":50,"locations":61,"responsibleParty":78,"collaborators":64,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":64,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":108,"whyStopped":64,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"After CPB Tranexamic Acid\u002FPlacebo","ACTIVE_COMPARATOR","In the intervention group, patients will receive intravenous administration (10-100 mL of saline placebo) at the induction of anesthesia as a bolus and\u002For continuous infusion. In addition, patients will receive intravenous administration (5 g of TxA) after heparin reversal (i.e., after CPB).",[13,14],"Drug: After CPB Tranexamic Acid","Drug: Before CPB Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Before CPB Tranexamic Acid\u002FPlacebo","In the control group, patients will receive an intravenous administration (1-10 g of TxA) at the induction of anesthesia as a bolus and\u002For continuous infusion (i.e., before CPB). In addition, patients will receive an intravenous administration (50 mL of saline placebo) after heparin reversal.",[19,20],"Drug: Before CPB Tranexamic Acid","Drug: After CPB Placebo",[22,29,34,40],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Before CPB Tranexamic Acid","Tranexamic acid 1 to 10 g (10 to 100 mL) administered intravenously as per standard care at the induction of anesthesia as a bolus and\u002For continuous infusion (i.e., before CPB).",[16],[28],"Cyklokapron",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"After CPB Tranexamic Acid","Tranexamic acid 5 g (50 mL) administered after heparin reversal (i.e., after CPB).",[9],[28],{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Before CPB Placebo","Placebo (10 to 100 mL saline) administered intravenously at the induction of anesthesia as a bolus and\u002For continuous infusion.",[9],[39],"Saline",{"type":23,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"After CPB Placebo","Placebo (50 mL saline) administered after heparin reversal.",[16],[39],[46],{"name":47,"affiliation":48,"role":49},"Andre Lamy, MD","Hamilton General Hospital","PRINCIPAL_INVESTIGATOR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Austin Browne","CONTACT","905-527-4322","40582","austin.browne@phri.ca",{"name":58,"role":53,"phone":54,"phoneExt":59,"email":60},"Patricia Power","44495","powerpat@hhsc.ca",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Hamilton Health Sciences - General Hospital",null,"Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":71,"coordinates":72},"Point",[73,74],-79.84963,43.25011,{"lat":74,"lon":73},[77],{"name":58,"role":53,"phone":54,"phoneExt":59,"email":60},{"type":79,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100563930","phase-3-decreasing-postoperative-blood-loss-and-seizures-by-timing-of-intravenous-tranexamic-acid-2-pilot-trial-100563930",false,"NCT06622564","Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial","Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION)-2 Pilot Trial","DEPOSITION-2","Inclusion Criteria:\n\n1. ≥18 years of age\n2. Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass\n3. Provide written informed consent\n\nExclusion Criteria:\n\n1. Allergy to tranexamic acid\n2. Fulfill any of the following transfusion risk factors (A-F):\n\n   A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active) E. Pre-operative thrombocytopenia (\\<50,000 platelets per µL) F. Pre-operative hemoglobin \\<110 g\u002FL\n3. Estimated glomerular filtration rate \\<30 mL\u002Fmin (CKD-EPI equation) or on dialysis\n4. Pre-operative hemoglobin \\>170 g\u002FL\n5. Expected circulatory arrest\n6. Pregnancy or breast feeding\n7. Previous enrollment in DEPOSITION trial\n8. Refusal of blood products (e.g., Jehovah's Witnesses)\n9. Isolated Pericardiectomy","ALL","18 Years","100 Years",{"count":92,"type":93},40,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are:\n\n* Is it feasible to conduct a larger definitive trial?\n* Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples?\n\nResearchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better.\n\nParticipants will:\n\n* Provide written informed consent\n* Receive tranexamic acid during surgery\n* Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.",[99,100,101],"Bleeding","Surgical Blood Loss","Seizures",[103,104,105,106,107],"cardiac surgery","tranexamic acid","cardiopulmonary bypass","seizure","blood transfusion","NOT_YET_RECRUITING","2024-09-30",{"date":111,"type":112},"2024-10-02","ACTUAL",{"date":114,"type":93},"2025-01-01",{"date":116,"type":93},"2026-02-01",{"name":5,"class":6},1]