What is tranexamic acid and desmopressin studying for patients with advanced kidney disease undergoing surgery?

These medications are being studied to see if they reduce bleeding during noncardiac surgery in people with severe kidney disease. The trial aims to understand their safety and effectiveness since this group has not been well studied before. The research is sponsored by Hamilton Health Sciences Corporation to guide future larger studies.

Who may be eligible for this chronic kidney disease clinical trial?

Adults aged 18 years or older with advanced kidney disease, defined by low kidney function or recent dialysis, who are scheduled for noncardiac surgery requiring at least an overnight hospital stay may be eligible. Both men and women can participate, but pregnant or breastfeeding women or those not using contraception are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic kidney disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider potential costs associated with getting to and from study visits.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06337838

BRACKETS Pilot Trial to Test Tranexamic Acid and Desmopressin for Reducing Bleeding in Adults with Severe Kidney Disease Undergoing Noncardiac Surgery

Led by Hamilton Health Sciences Corporation · Updated on 2026-05-22

100

Participants Needed

Research Sites

17 weeks

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Ingrid Copland

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