Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Actively Recruiting
About This Study
The BRACKETS pilot trial is a multicentre, randomized controlled trial evaluating the feasibility and safety of prophylactic preoperative tranexamic acid (TXA) and desmopressin in patients with advanced CKD or AKI undergoing noncardiac surgery. Utilizing a partial factorial design, the study compares TXA versus placebo and desmopressin versus placebo to address the increased bleeding risk associated with impaired primary hemostasis in this population. The trial aims to provide preliminary efficacy data and pharmacokinetic profiles to inform dose selection for a larger international phase. Investigators seek to determine if these generic agents reduce perioperative bleeding complications in a high-risk cohort typically excluded from major surgical trials.
Who Can Participate?
✓ Inclusion Criteria
- •Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial
- •One of either: 1.1. 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.
- •To be eligible for the desmopressin factorial, patients must be eligible for the TXA factorial.
✗ Exclusion Criteria
- •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
- •Exclusion criteria specific to the desmopressin factorial:
- •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.