nctId: NCT06337838 id: 2024.BRACKETS-Pilot briefTitle: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial acronym: BRACKETS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-03-29 date: 2024-03-29 name: Population Health Research Institute class: OTHER briefSummary: 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. conditions: Chronic Kidney Diseases conditions: Acute Kidney Injury conditions: Bleeding conditions: Surgery studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Study drugs will be sourced locally and will be prepared by appropriately qualified center personnel who are independent of the study team to ensure blinding is maintained. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Desmopressin Injectable Solution name: Tranexamic Acid Injectable Product name: Placebo measure: Rate of recruitment measure: Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial measure: Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial measure: Completion of 30-day follow-up measure: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS) measure: Reoperation for reasons of bleeding measure: Blood (red blood cells or whole blood) transfused measure: Blood (red blood cells or whole blood) transfused measure: Any blood transfusion (red blood cells or whole blood) measure: Any blood transfusion (red blood cells or whole blood) measure: Lowest measured hemoglobin concentration measure: Most recent hemoglobin concentration measure: Death measure: Major arterial and venous thrombosis measure: Myocardial Injury after Noncardiac Surgery (MINS) measure: Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction measure: MINS that is an isolated ischemic troponin elevation measure: Stroke measure: Non-hemorrhagic stroke measure: Hemorrhagic stroke measure: Peripheral arterial thrombosis measure: Thrombosis of arteriovenous fistula or graft measure: Symptomatic proximal venous thromboembolism measure: Symptomatic pulmonary embolism measure: Symptomatic proximal leg or arm deep venous thrombosis (DVT) measure: Non-fatal cardiac arrest measure: Coronary revascularization procedure measure: Clinically important atrial fibrillation or flutter measure: Acute heart failure measure: Acute kidney injury (for patients not receiving dialysis before surgery) measure: New start of dialysis measure: Seizure measure: Clinically significant intraoperative hypotension measure: Clinically significant postoperative hypotension measure: Sepsis measure: Duration of surgery measure: Receipt of platelets measure: Receipt of fibrinogen measure: Receipt of fresh frozen plasma measure: Receipt of cryoprecipitate measure: Receipt of recombinant Factor VIIa measure: Receipt of prothrombin complex concentrate measure: Prescribed erythropoiesis stimulating agent measure: Severe hyponatremia measure: Duration of hospital stay after surgery measure: Duration of critical care stay after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False