Can a simple drug stop dangerous bleeding in kidney patients during surgery?
NCT ID NCT06337838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving two common drugs, tranexamic acid and desmopressin, before surgery can reduce bleeding in patients with chronic kidney disease or acute kidney injury. About 100 adults having noncardiac surgery will be randomly assigned to receive one or both drugs or a placebo. The goal is to see if these drugs are safe and effective at preventing serious bleeding complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier de L'Universite de Montreal (CHUM)
ACTIVE_NOT_RECRUITINGMontreal, Quebec, H2X 0A9, Canada
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London Health Sciences Centre
RECRUITINGLondon, Ontario, N6A 5A5, Canada
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McGill University University Health Centre
RECRUITINGMontreal, Quebec, H3H 2R9, Canada
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