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
Hamilton Health Sciences Corporation
100 participants
Jun 9, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- One of either:
- eGFR \<25 ml/min/1.73m2 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;
- Planned noncardiac surgery (elective, urgent, or emergency surgery);
- Expected to require at least an overnight hospital admission after surgery;
- Age ≥18 years; and
- Informed consent is obtained to participate in the BRACKETS-Pilot Trial.
- \. Included in the TXA factorial.
Exclusion Criteria16
- Undergoing cardiac surgery;
- Undergoing intracranial neurosurgery;
- Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- Hypersensitivity or known allergy to TXA;
- History of seizure disorder;
- Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;
- History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;
- 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
- Previously enrolled in the BRACKETS-Pilot Trial.
- Eligibility criteria specific to the desmopressin factorial component of trial
- The hospital does not have access to desmopressin;
- Planned use of prophylactic desmopressin;
- Most recent serum sodium concentration \< 130 mEq/L;
- Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or
- Hypersensitivity or known allergy to desmopressin.
Interventions
Intravenous desmopressin, 20 mcg, single dose administration.
Intravenous tranexamic acid, 1000 mg single dose administration for patients with eGFR\<25 not yet receiving dialysis OR 500 mg single dose administration for patients receiving dialysis.
Intravenous 0.9% saline solution
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06337838