Reducing surgical bleeding in adults with advanced or acute kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BRACKETS pilot is a multicentre, randomized, placebo-controlled partial factorial trial testing prophylactic preoperative tranexamic acid (TXA) and desmopressin versus placebo in adults with severe chronic kidney disease or recent acute kidney injury undergoing noncardiac surgery. Participants are randomized to receive TXA or placebo and, in a partial factorial design, may also be randomized to desmopressin or its placebo; interventions are administered perioperatively with blinded outcome assessment. The pilot will test feasibility, provide preliminary efficacy and safety data, and collect pharmacokinetic information to inform dose selection in patients with impaired renal function. Findings will be used to design a larger international trial to determine whether these inexpensive, generic drugs can safely reduce perioperative bleeding in this high-risk group.

Why it matters

Who can join: the full rules

Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial Inclusion Criteria:

1. 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;
2. Planned noncardiac surgery (elective, urgent, or emergency surgery);
3. Expected to require at least an overnight hospital admission after surgery;
4. Age ≥18 years; and
5. Informed consent is obtained to participate in the BRACKETS-Pilot Trial.

Exclusion Criteria:

1. Undergoing cardiac surgery;
2. Undergoing intracranial neurosurgery;
3. Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
4. Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
5. Hypersensitivity or known allergy to TXA;
6. History of seizure disorder;
7. Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;
8. History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;
9. 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
10. Previously enrolled in the BRACKETS-Pilot Trial.

Eligibility criteria specific to the desmopressin factorial component of trial

Inclusion criteria:

1\. Included in the TXA factorial.

Exclusion criteria:

1. The hospital does not have access to desmopressin;
2. Planned use of prophylactic desmopressin;
3. Most recent serum sodium concentration \< 130 mEq/L;
4. Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or
5. Hypersensitivity or known allergy to desmopressin.

Where it's running

• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• McGill University University Health Centre
  Montreal, Quebec, Canada Recruiting
• Centre Hospitalier de L'Universite de Montreal (CHUM)
  Montreal, Quebec, Canada Active not recruiting

Study contacts

• Principal investigator: Pavel Roshanov, MC,MSc,FRCPC — Western University
• Study coordinator: Ingrid Copland
• Email: brackets@phri.ca
• Phone: 905-296-5754

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.