[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533720":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":90,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":42,"eligibilityCriteria":102,"healthyVolunteers":99,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":42,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":42,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamic Acid","EXPERIMENTAL","Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg\u002Fkg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg\u002Fkg\u002Fhr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.",[13],"Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION",{"label":15,"type":16,"description":11,"interventionNames":17},"Matching Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION","Tranexamic acid 20 mg\u002Fkg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg\u002Fkg\u002Fhr infusion of TXA, for the duration of surgery. Treatment is blinded.",[9],[26],"TXA",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo","0.9% normal saline 20ml\u002Fkg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml\u002Fkg\u002Fhr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.",[15],[32],"Normal saline (0.9% sodium chloride)",[34],{"name":35,"affiliation":36,"role":37},"Stephen Lownie, MD","Nova Scotia Health Authority- Queen Elizabeth II HSC","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","902-473-6449",null,"stephen.lownie@nshealth.ca",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Lisa Julien, RN BScN","902-473-3877","lisa.julien@nshealth.ca",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center","RECRUITING","Halifax","Nova Scotia","B3H3A7","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-63.57688,44.64269,{"lat":61,"lon":60},[64,65,67,70,72,74,76,78,80,82,84,86,88],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":66,"role":40,"phone":46,"phoneExt":42,"email":47},"Lisa Julien, RN BSCN CCRP",{"name":68,"role":69,"phone":42,"phoneExt":42,"email":42},"Sean Christie, MD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":42,"phoneExt":42,"email":42},"Sean Barry, MD",{"name":73,"role":69,"phone":42,"phoneExt":42,"email":42},"Adrienne Weeks, MD",{"name":75,"role":69,"phone":42,"phoneExt":42,"email":42},"Dan McNeely, MD",{"name":77,"role":69,"phone":42,"phoneExt":42,"email":42},"Lutz Weise, MD",{"name":79,"role":69,"phone":42,"phoneExt":42,"email":42},"David Clarke, MD",{"name":81,"role":69,"phone":42,"phoneExt":42,"email":42},"Gwynedd Pickett, MD",{"name":83,"role":69,"phone":42,"phoneExt":42,"email":42},"Simon Walling, MD",{"name":85,"role":69,"phone":42,"phoneExt":42,"email":42},"Genevieve McKinnon, MD",{"name":87,"role":69,"phone":42,"phoneExt":42,"email":42},"Suna Jung, MD",{"name":89,"role":69,"phone":42,"phoneExt":42,"email":42},"Jacob Alant, MD",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Stephen Lownie","Professor",[95],{"name":96,"class":6},"Dalhousie University","100533720","phase-3-the-effects-of-intraoperative-tranexamic-acid-on-perioperative-bleeding-in-craniotomies-100533720",false,"NCT06229483","The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies","Inclusion Criteria are the following:\n\n1. Adult male or female, between 18-80 years of age.\n2. Patients are scheduled to undergo a craniotomy for tumor resection.\n3. Patients\u002F Substitute Decision Maker have given written consent to participate.\n\nExclusion Criteria are the following: Patients who meet any of the following exclusion criteria will not be eligible.\n\n1. Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.\n2. Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.\n3. Patients with renal impairment and eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2 as determined by the lab or calculated by using the Cockcroft Gault formula or end stage renal disease currently on dialysis.\n4. Female subjects who are pregnant or currently breastfeeding.\n5. Patients with Class 3 (high-risk) obesity BMI ≥ to 40.\n6. Patients undergoing emergency craniotomy or mini craniotomy or craniectomies.\n7. Patients who received embolization prior to surgery.","ALL","18 Years","80 Years",{"count":107,"type":108},102,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are:\n\n1. Does TXA 20 mg\u002Fkg IV bolus of TXA, and 1 mg\u002Fkg\u002Fhr infusion of TXA reduce the amount of estimated blood loss during surgery?\n2. Does TXA 20 mg\u002Fkg IV bolus of TXA, and 1 mg\u002Fkg\u002Fhr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg\u002Fkg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg\u002Fkg\u002Fhr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.",[114,115],"Brain Tumor","Bleeding","2026-03-18",{"date":118,"type":119},"2026-03-19","ACTUAL",{"date":121,"type":119},"2024-04-03",{"date":123,"type":108},"2028-12-31",{"name":92,"class":6},1]