Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial (NCT06337838) | Clinical Trial Compass
RecruitingPhase 3
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Canada100 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. One of either:
✓.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.
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;
What they're measuring
1
Rate of recruitment
Timeframe: Through study completion, an average of 1.5 years
2
Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial
Timeframe: Day of surgery
3
Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial