Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial

2024.BRACKETS-Pilot

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.

2024-06-01

2025-12-01

2026-03-01

Not yet recruiting

Early phase I

100

Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial Inclusion Criteria: 1. One of either: 1.1. eGFR \<25 ml/min/1.73m2 estimated using 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 hemodialysis or peritoneal dialysis in the preceding 7 days and expected to require dialysis after surgery; 2. Planned noncardiac surgery; 3. Expected to require at least an overnight hospital admission after surgery; 4. Age ≥18 years; and 5. Informed consent is obtained to participate in the BRACKETS-Pilot Trial. Exclusion Criteria: 1. Undergoing cardiac surgery; 2. Undergoing intracranial neurosurgery; 3. Undergoing solid organ transplantation surgery (e.g., kidney, liver, pancreas, heart, lung, small bowel); 4. Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access; 5. Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid; 6. Hypersensitivity or known allergy to TXA; 7. History of seizure disorder; 8. Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, venous thromboembolism, or dialysis access thrombosis of an arteriovenous fistula or graft; 9. History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome; 10. Women of childbearing potential who are not taking effective contraception, pregnant, or breastfeeding; or 11. Previously enrolled in the BRACKETS-Pilot Trial. Eligibility criteria specific to the desmopressin factorial component of trial Inclusion criteria: 1. Included in the TXA factorial. Exclusion criteria: 1. The hospital does not have access to desmopressin; 2. Planned use of prophylactic desmopressin; 3. Most recent serum sodium concentration \< 130 mEq/L; 4. Known or suspected von Willebrand disease (any kind), or platelet function disorder; or 5. Hypersensitivity or known allergy to desmopressin.

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2024-03-29