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Clinical Trial Details

Trial ID: L0428
Source ID: NCT06337838
Associated Drug: Desmopressin Injectable Solution
Title: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Acronym: BRACKETS
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Acute Kidney Injury|Bleeding|Surgery
Interventions: DRUG: Desmopressin Injectable Solution|DRUG: Tranexamic Acid Injectable Product|OTHER: Placebo
Outcome Measures: Primary: Rate of recruitment, A rate of 0.25 patients per study site per week, Through study completion, an average of 1.5 years|Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial, Account of whether the patient began to receive study drug for the TXA factorial within an hour before skin incision. Target ≥80% of participants, Day of surgery|Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial, Account of whether the patient began to receive study drug for the desmopressin factorial within an hour before skin incision. Target ≥80% of participants, Day of surgery|Completion of 30-day follow-up, Account of whether the patient or their next-of-kin could be contacted and completed the 30-day post-randomization assessment. Target ≥80% of participants, 30 days after randomization | Secondary: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS), Number of patients who experience BIMS, 30 days after randomization|Reoperation for reasons of bleeding, Number of patients who return to the operating room for surgical management of suspected documented bleeding, 30 days after randomization|Blood (red blood cells or whole blood) transfused, Number of units of blood transfused., 30 days after randomization|Blood (red blood cells or whole blood) transfused, Number of units of blood transfused., Up to and including postoperative day 3 after surgery|Any blood transfusion (red blood cells or whole blood), Number of units of blood transfused., 30 days after randomization|Any blood transfusion (red blood cells or whole blood), Number of units of blood transfused., Up to and including postoperative day 3|Lowest measured hemoglobin concentration, The mean absolute difference for continuous outcomes using linear regression with treatment allocation, 30 days after randomization|Most recent hemoglobin concentration, The mean absolute difference for continuous outcomes using linear regression with treatment allocation, 30 days after randomization|Death, Number of patients who die of any cause, 30 days after randomization|Major arterial and venous thrombosis, (i.e., composite of myocardial injury after noncardiac surgery \[MINS\], stroke, peripheral arterial thrombosis, dialysis vascular access thrombosis requiring anticoagulation or intervention, and symptomatic venous thromboembolism), 30 days after randomization|Myocardial Injury after Noncardiac Surgery (MINS), Number of patients who experience MINS, 30 days after randomization|Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction, Number of patients who experience MINS that meets criteria for myocardial infarction (based on the Fourth Universal Definition of myocardial infarction), 30 days after randomization|MINS that is an isolated ischemic troponin elevation, Number of patients who experience MINS that is an isolated ischemic troponin elevation, 30 days after randomization|Stroke, Number of patients experiencing a stroke, 30 days after randomization|Non-hemorrhagic stroke, Number of patients who experience a non-hemorrhagic stroke, 30 days after randomization|Hemorrhagic stroke, Number of patients who experience a hemorrhagic stroke, 30 days after randomization|Peripheral arterial thrombosis, Number of patients who experience a peripheral arterial thrombosis, 30 days after randomization|Thrombosis of arteriovenous fistula or graft, Number of patients who have thrombosis of arteriovenous fistula or graft, 30 days after randomization|Symptomatic proximal venous thromboembolism, Number of patients who experience symptomatic proximal venous thromboembolism, 30 days after randomization|Symptomatic pulmonary embolism, Number of patients who experience a symptomatic pulmonary embolism, 30 days after randomization|Symptomatic proximal leg or arm deep venous thrombosis (DVT), Number of patients who experience a symptomatic proximal leg or arm DVT, 30 days after randomization|Non-fatal cardiac arrest, Number of patients who experience non-fatal cardiac arrest, 30 days after randomization|Coronary revascularization procedure, Number of patients who undergo coronary revascularization procedure, 30 days after randomization|Clinically important atrial fibrillation or flutter, Number of patients who experience clinically important atrial fibrillation or flutter, 30 days after randomization|Acute heart failure, Number of patients who experience acute heart failure, 30 days after randomization|Acute kidney injury (for patients not receiving dialysis before surgery), Number of patients who experience an acute kidney injury, 30 days after randomization|New start of dialysis, Number of patients who require new start of dialysis, 30 days after randomization|Seizure, Number of patients who experience a seizure, 30 days after randomization|Clinically significant intraoperative hypotension, Number of patients who experience clinically significant intraoperative hypotension, 30 days after randomization|Clinically significant postoperative hypotension, Number of patients who experience clinically significant postoperative hypotension, Up to and including the end of postoperative day 1|Sepsis, Number of patients who experience sepsis, 30 days after randomization|Duration of surgery, The time from skin incision to closure, in minutes., 30 days after randomization|Receipt of platelets, Any transfusion of this blood product, 30 days after randomization|Receipt of fibrinogen, Any transfusion of this blood product, 30 days after randomization|Receipt of fresh frozen plasma, Any transfusion of this blood product, 30 days after randomization|Receipt of cryoprecipitate, Any transfusion of this blood product, 30 days after randomization|Receipt of recombinant Factor VIIa, Number of patients receiving recombinant factor VIIa, 30 days after randomization|Receipt of prothrombin complex concentrate, Number of patients who receive prothrombin complex concentrate, 30 days after randomization|Prescribed erythropoiesis stimulating agent, Number of patients receiving a weekly dose of erythropoiesis stimulating agent on prescription active at 30 days, 30 days after randomization|Severe hyponatremia, Measured serum sodium concentration \<125 meq/L, Up to and including the end of postoperative day 1|Duration of hospital stay after surgery, Cumulative number of nights spent in an acute care hospital, Day of surgery and ending the day of discharge|Duration of critical care stay after surgery, Cumulative number of nights spent in an intensive care unit, Day of surgery and ending the day of discharge
Sponsor/Collaborators: Sponsor: Population Health Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-12
Completion Date: 2026-04
Results First Posted:
Last Update Posted: 2024-11-21
Locations:
URL: https://clinicaltrials.gov/show/NCT06337838