[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542051":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":104,"collaborators":106,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":47,"enrollmentInfo":119,"targetDuration":47,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":62,"whyStopped":47,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin.","EXPERIMENTAL","Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with estimated glomerular filtration rate (eGFR) \\\u003C25 ml\u002Fmin\u002F1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.\n\nWithin 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin intervention group will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes.",[13,14],"Drug: Desmopressin Injectable Solution","Drug: Tranexamic Acid Injectable Product",{"label":16,"type":10,"description":17,"interventionNames":18},"Prophylactic intravenous tranexamic acid and placebo.","Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with eGFR \\\u003C25 ml\u002Fmin\u002F1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.\n\nWithin 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes.",[14,19],"Other: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Prophylactic intravenous desmopressin and placebo.","Within 20 minutes preceding anticipated skin incision, patients will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. Patients will not receive prophylactic tranexamic acid.\n\nWithin 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group.",[13,19],{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo and placebo.","PLACEBO_COMPARATOR","Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group.\n\nWithin 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes.",[19],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Desmopressin Injectable Solution","Intravenous desmopressin, 20 mcg, single dose administration.",[21,9],[36],"DDAVP",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Tranexamic Acid Injectable Product","Intravenous tranexamic acid, 1000 mg single dose administration for patients with eGFR\\\u003C25 not yet receiving dialysis OR 500 mg single dose administration for patients receiving dialysis.",[16,9],[42],"Cyklokapron",{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Placebo","Intravenous 0.9% saline solution",[25,21,16],null,[49],{"name":50,"affiliation":51,"role":52},"Pavel Roshanov, MC,MSc,FRCPC","Western University","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":47,"email":58},"Ingrid Copland","CONTACT","905-296-5754","brackets@phri.ca",[60,82,93],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A 5A5","Canada","CA",{"type":69,"coordinates":70},"Point",[71,72],-81.23304,42.98339,{"lat":72,"lon":71},[75,80],{"name":76,"role":56,"phone":77,"phoneExt":78,"email":79},"Cadence Baker","519-685-8500","34769","cadence.baker@lhsc.on.ca",{"name":81,"role":52,"phone":47,"phoneExt":47,"email":47},"Pavel Roshanov, MD",{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":66,"countryCode":67,"cosmosGeoPoint":88,"geoPoint":92,"contacts":47},"Centre Hospitalier de L'Universite de Montreal (CHUM)","ACTIVE_NOT_RECRUITING","Montreal","Quebec","H2X 0A9",{"type":69,"coordinates":89},[90,91],-73.58781,45.50884,{"lat":91,"lon":90},{"facility":94,"status":62,"city":85,"state":86,"zip":95,"country":66,"countryCode":67,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"McGill University University Health Centre","H3H 2R9",{"type":69,"coordinates":97},[90,91],{"lat":91,"lon":90},[100,102],{"name":101,"role":56,"phone":47,"phoneExt":47,"email":47},"Lin Jawhar",{"name":103,"role":52,"phone":47,"phoneExt":47,"email":47},"Shaifali Sandal, MD",{"type":105,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[107],{"name":108,"class":6},"Population Health Research Institute","100542051","phase-3-bleeding-reduction-in-acute-and-chronic-kidney-patients-having-surgery-brackets-pilot-trial-100542051",false,"NCT06337838","Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial","Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial","BRACKETS","Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial Inclusion Criteria:\n\n1. One of either:\n\n   1.1. eGFR \\\u003C25 ml\u002Fmin\u002F1.73m2 estimated using the CKD-Epi 2009 or 2021creatinine-based equation from the most recent serum creatinine measurement done in the previous 6 months; or 1.2. Receipt of dialysis (including hemodialysis, peritoneal dialysis, hemofiltration, or hemodiafiltration) within the last 7 days;\n2. Planned noncardiac surgery (elective, urgent, or emergency surgery);\n3. Expected to require at least an overnight hospital admission after surgery;\n4. Age ≥18 years; and\n5. Informed consent is obtained to participate in the BRACKETS-Pilot Trial.\n\nExclusion Criteria:\n\n1. Undergoing cardiac surgery;\n2. Undergoing intracranial neurosurgery;\n3. Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;\n4. Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;\n5. Hypersensitivity or known allergy to TXA;\n6. History of seizure disorder;\n7. Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;\n8. History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;\n9. Women who are known to be pregnant, breastfeeding, or who meet both of the following criteria: i) are of childbearing potential and do not have a negative pregnancy test documented in the 7 days before surgery, AND ii) are not using effective contraception; or\n10. Previously enrolled in the BRACKETS-Pilot Trial.\n\nEligibility criteria specific to the desmopressin factorial component of trial\n\nInclusion criteria:\n\n1\\. Included in the TXA factorial.\n\nExclusion criteria:\n\n1. The hospital does not have access to desmopressin;\n2. Planned use of prophylactic desmopressin;\n3. Most recent serum sodium concentration \\\u003C 130 mEq\u002FL;\n4. Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or\n5. Hypersensitivity or known allergy to desmopressin.","ALL","18 Years",{"count":120,"type":121},100,"ESTIMATED","INTERVENTIONAL",[124],"PHASE3","The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.",[127,128,129,130],"Chronic Kidney Diseases","Acute Kidney Injury","Bleeding","Surgery",[132,133,134],"Major Noncardiac Surgery","Tranexamic Acid","Desmopressin","2026-05-20",{"date":137,"type":138},"2026-05-22","ACTUAL",{"date":140,"type":138},"2025-06-09",{"date":142,"type":121},"2027-06",{"name":5,"class":6},3]