NCT06337838 Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
| NCT ID | NCT06337838 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2025-06-09 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Pavel Roshanov, MC,MSc,FRCPC
PRINCIPAL INVESTIGATOR
Western University
Frequently Asked Questions
Who can join the NCT06337838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06337838 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT06337838 currently recruiting?
Yes, NCT06337838 is actively recruiting participants. Contact the research team at brackets@phri.ca for enrollment information.
Where is the NCT06337838 trial being conducted?
This trial is being conducted at London, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06337838 clinical trial?
NCT06337838 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Pavel Roshanov, MC,MSc,FRCPC at Western University. The trial plans to enroll 100 participants.
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