Clinical trial 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?
An investigational intravenous medicine being studied as a potential treatment to reduce bleeding risk in patients with chronic kidney disease undergoing non‑cardiac surgery. It is designed to stimulate V2 receptors, raising von Willebrand factor and factor VIII levels to improve platelet function.
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
- This study aims to find out if taking tranexamic acid or desmopressin before surgery helps prevent bleeding in people with kidney disease.
- Who it's for
- The study is looking for adults who have acute or chronic kidney disease and are scheduled to have surgery.
- What's involved
- Participants will be randomly assigned to receive either a medicine or a placebo (sugar pill) before their surgery to see if it reduces bleeding.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
- 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.
- 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)...
- 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 is enrolling
- London, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at London, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.