Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Recruiting · NCT06337838 · Interventional (participants receive a specific treatment) · Lead sponsor: Hamilton Health Sciences Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Desmopressin Injectable SolutionPlaceboTranexamic Acid Injectable Product
What this trial 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
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
- Inclusion criteria:
- \. Included in the TXA factorial.
- Exclusion criteria:
- 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 it is running
3 locations listed.
- 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