Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

What this study is about

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.

Who can join (things the study team will check)

Criteria

• 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.

🚫 You may not be able to join if…

• 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

✅ You may be able to join if…

• Included in the TXA factorial.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• London Health Sciences Centre, London, Ontario, Canada
• Centre Hospitalier de L'Universite de Montreal (CHUM), Montreal, Quebec, Canada
• McGill University University Health Centre, Montreal, Quebec, Canada

Who to contact

Ingrid Copland · 905-296-5754 · brackets@phri.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06337838.