RecruitingPhase 3NCT06337838

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial


Sponsor

Hamilton Health Sciences Corporation

Enrollment

100 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study, called BRACKETS, tests whether the blood-clot-reducing drug tranexamic acid (TXA) can safely reduce bleeding in people with significant kidney disease who are having non-cardiac surgery. **You may be eligible if...** - You are 18 or older - You have severely reduced kidney function (eGFR below 25 mL/min) OR you have been on dialysis within the past 7 days - You are scheduled for non-cardiac surgery (planned or urgent) - You are expected to stay in the hospital overnight after surgery **You may NOT be eligible if...** - You are having heart surgery or brain surgery - You are having surgery to create or revise an arteriovenous (AV) access for dialysis - You have a history of blood clots in veins or arteries - You have active bleeding or a known bleeding disorder - (Other specific exclusions may apply per the study protocol) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDesmopressin Injectable Solution

Intravenous desmopressin, 20 mcg, single dose administration.

DRUGTranexamic Acid Injectable Product

Intravenous tranexamic acid, 1000 mg single dose administration for patients with eGFR\<25 not yet receiving dialysis OR 500 mg single dose administration for patients receiving dialysis.

OTHERPlacebo

Intravenous 0.9% saline solution


Locations(3)

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

View Full Details on ClinicalTrials.gov

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NCT06337838


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