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New treatment option for Chronic Kidney Diseases
Official title Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
ClinicalTrials.gov ID: NCT06337838
What this study is testing
What is Desmopressin Injectable Solution?
Desmopressin Injectable Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney diseases.
Also referred to as DDAVP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial
- 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...
- Planned noncardiac surgery (elective, urgent, or emergency surgery);
- Expected to require at least an overnight hospital admission after surgery;
- Age ≥18 years; and
You likely can't join if
- Undergoing cardiac surgery;
- Undergoing intracranial neurosurgery;
- Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- Hypersensitivity or known allergy to TXA;
- History of seizure disorder;
See the full eligibility criteria
- Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial
- 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...
- Planned noncardiac surgery (elective, urgent, or emergency surgery);
- Expected to require at least an overnight hospital admission after surgery;
- Age ≥18 years; and
- Informed consent is obtained to participate in the BRACKETS-Pilot Trial.
- Undergoing cardiac surgery;
- Undergoing intracranial neurosurgery;
- Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- Hypersensitivity or known allergy to TXA;
- 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;
- 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)...
- 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:
- 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
- Hypersensitivity or known allergy to desmopressin.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.