Actively Recruiting
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Led by Hamilton Health Sciences Corporation · Updated on 2026-05-22
100
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
P
Population Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of prophylactic preoperative tranexamic acid (TXA) and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery. This pilot study aims to assess the feasibility and design of a larger trial, provide preliminary safety and efficacy data, and gather pharmacokinetic information to help select appropriate dosages. The study addresses a gap since patients with severe kidney disease have been excluded from large trials despite bleeding risks during surgery. Participants will be randomly assigned to receive intravenous TXA, desmopressin, both, or placebos shortly before surgery. TXA dosing varies based on kidney function and dialysis status, with either 1000 mg or 500 mg infused over 10 minutes. Desmopressin is given as a 20 mcg infusion over 30 minutes. Placebo infusions use saline solutions matching the timing and volume of the active drugs. Treatment is administered within 20 minutes before the skin incision. During the study, researchers will monitor recruitment rates, drug administration timing, and conduct a 30-day follow-up after surgery. They will assess bleeding outcomes, blood transfusions, surgical complications, cardiovascular events, kidney function changes, and other safety measures. The total observation period includes the day of surgery and 30 days afterward, tracking hospital stay duration and postoperative recovery indicators to evaluate the interventions' impact comprehensively.
CONDITIONS
Brief Title
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Advanced kidney disease defined by eGFR <25 ml/min/1.73m2 or receipt of dialysis within the last 7 days
- Scheduled for noncardiac surgery (elective, urgent, or emergency)
- Expected to require at least an overnight hospital stay after surgery
- Provided informed consent to participate in the trial
You will not qualify if you...
- Undergoing cardiac surgery
- Undergoing intracranial neurosurgery
- Undergoing surgery to create or revise arteriovenous fistula or graft for dialysis access
- Planned use of prophylactic systemic tranexamic acid or ε-aminocaproic acid
- Known allergy or hypersensitivity to tranexamic acid
- History of seizure disorder
- Recent stroke, heart attack, arterial thrombosis, deep vein thrombosis, pulmonary embolism, or thrombosis of dialysis access within the last 90 days
- History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome
- Women who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test and effective contraception
- Previously enrolled in this trial
- Hospital does not have access to desmopressin
- Planned use of prophylactic desmopressin
- Recent serum sodium concentration below 130 mEq/L
- Known or suspected von Willebrand disease, hemophilia, or platelet function disorder
- Known allergy or hypersensitivity to desmopressin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive a single intravenous dose of tranexamic acid and/or desmopressin shortly before surgery to help reduce bleeding risk.
1 treatment visit (in-person) on the day of surgery
Duration - 30 days after surgery
Participants are monitored for safety and outcomes including bleeding, transfusions, and other health events after surgery.
Follow-up visits or assessments up to 30 days after surgery
Trial Site Locations
Total: 3 locations
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
2
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Active, Not Recruiting
3
McGill University University Health Centre
Montreal, Quebec, Canada, H3H 2R9
Actively Recruiting
Research Team
I
Ingrid Copland
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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