protocolSection identificationModule nctId: NCT06337838, orgStudyIdInfo id: 2024.BRACKETS-Pilot, briefTitle: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial, acronym: BRACKETS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Population Health Research Institute, class: OTHER, descriptionModule 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., conditionsModule conditions: Chronic Kidney Diseases, conditions: Acute Kidney Injury, conditions: Bleeding, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo 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, maskingInfo 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, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Desmopressin Injectable Solution, interventions name: Tranexamic Acid Injectable Product, interventions name: Placebo, outcomesModule primaryOutcomes measure: Rate of recruitment, primaryOutcomes measure: Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial, primaryOutcomes measure: Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial, primaryOutcomes measure: Completion of 30-day follow-up, secondaryOutcomes measure: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS), secondaryOutcomes measure: Reoperation for reasons of bleeding, secondaryOutcomes measure: Blood (red blood cells or whole blood) transfused, secondaryOutcomes measure: Blood (red blood cells or whole blood) transfused, secondaryOutcomes measure: Any blood transfusion (red blood cells or whole blood), secondaryOutcomes measure: Any blood transfusion (red blood cells or whole blood), secondaryOutcomes measure: Lowest measured hemoglobin concentration, secondaryOutcomes measure: Most recent hemoglobin concentration, secondaryOutcomes measure: Death, secondaryOutcomes measure: Major arterial and venous thrombosis, secondaryOutcomes measure: Myocardial Injury after Noncardiac Surgery (MINS), secondaryOutcomes measure: Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction, secondaryOutcomes measure: MINS that is an isolated ischemic troponin elevation, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Non-hemorrhagic stroke, secondaryOutcomes measure: Hemorrhagic stroke, secondaryOutcomes measure: Peripheral arterial thrombosis, secondaryOutcomes measure: Thrombosis of arteriovenous fistula or graft, secondaryOutcomes measure: Symptomatic proximal venous thromboembolism, secondaryOutcomes measure: Symptomatic pulmonary embolism, secondaryOutcomes measure: Symptomatic proximal leg or arm deep venous thrombosis (DVT), secondaryOutcomes measure: Non-fatal cardiac arrest, secondaryOutcomes measure: Coronary revascularization procedure, secondaryOutcomes measure: Clinically important atrial fibrillation or flutter, secondaryOutcomes measure: Acute heart failure, secondaryOutcomes measure: Acute kidney injury (for patients not receiving dialysis before surgery), secondaryOutcomes measure: New start of dialysis, secondaryOutcomes measure: Seizure, secondaryOutcomes measure: Clinically significant intraoperative hypotension, secondaryOutcomes measure: Clinically significant postoperative hypotension, secondaryOutcomes measure: Sepsis, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Receipt of platelets, secondaryOutcomes measure: Receipt of fibrinogen, secondaryOutcomes measure: Receipt of fresh frozen plasma, secondaryOutcomes measure: Receipt of cryoprecipitate, secondaryOutcomes measure: Receipt of recombinant Factor VIIa, secondaryOutcomes measure: Receipt of prothrombin complex concentrate, secondaryOutcomes measure: Prescribed erythropoiesis stimulating agent, secondaryOutcomes measure: Severe hyponatremia, secondaryOutcomes measure: Duration of hospital stay after surgery, secondaryOutcomes measure: Duration of critical care stay after surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False