Testing Desmopressin Injectable Solution against a placebo for chronic kidney diseases
Official title: 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
- Phase 3
- 4 groups
- Sites in London and Montreal
- Recruiting
Interventions
- Medication
Desmopressin Injectable Solution
Intravenous desmopressin, 20 mcg, single dose administration.
- Medication
Tranexamic 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.
- Other intervention
Placebo
Intravenous 0.9% saline solution
Canadian Sites (3)
2 of 3 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
McGill University University Health Centre
Montreal, Quebec
- Not currently recruiting
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years; and
- +One of either:
- +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;
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → is obtained to participate in the BRACKETS-Pilot Trial.
- +Planned noncardiac surgery (elective, urgent, or emergency surgery);
- +Expected to require at least an overnight hospital admission after surgery;
Exclusion
- −Hypersensitivity or known allergy to TXA;
- −Hypersensitivity or known allergy to desmopressin.
- −Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- −History of seizure disorder;
- −Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;
- −History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;
- −Previously enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the BRACKETS-Pilot Trial.
- −Eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → specific to the desmopressin factorial component of trial
- −Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −\. Included in the TXA factorial.
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −The hospital does not have access to desmopressin;
- −Planned use of prophylactic desmopressin;
- −Most recent serum sodium concentration \< 130 mEq/L;
- −Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or
- −Undergoing cardiac surgery;
- −Undergoing intracranial neurosurgery;
- −Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives one or more of: Desmopressin Injectable Solution and Tranexamic Acid Injectable Product.
Registry label: A: Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin.
Group B receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, together with one or more of: Tranexamic Acid Injectable Product.
Registry label: B: Prophylactic intravenous tranexamic acid and placebo.
Group C receives Placebo, together with one or more of: Desmopressin Injectable Solution.
Registry label: C: Prophylactic intravenous desmopressin and placebo.
Group D, the placebo group, receives Placebo.
Registry label: D: Placebo and placebo.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: Through study completion, an average of 1.5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Rate of recruitment — measured over Through study completion, an average of 1.5 years.
Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial — measured over Day of surgery.
Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial — measured over Day of surgery.
Completion of 30-day follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → — measured over 30 days after randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06337838 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Desmopressin Injectable SolutionDrug
Intravenous desmopressin, 20 mcg, single dose administration.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Tranexamic Acid Injectable ProductDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Intravenous 0.9% saline solution
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through study completion, an average of 1.5 years.
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: London, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.