DRUG
Desmopressin Injectable Solution
Intravenous desmopressin, 20 mcg, single dose administration.
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Status
Recruiting
Phase
Phase 3
Enrollment
100
Locations
3
Results
Not posted
Publications
0
Study summary
What the protocol is 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.
Full detailed description
Perioperative administration of TXA reduces bleeding risk in surgical patients. However, large clinical trials have excluded patients with advanced kidney disease, so the benefits remain uncertain in this population, and there is potential for harm. The benefit of desmopressin, which is purported to more directly address the defect of primary hemostasis believed important in severe kidney disease more directly than TXA, has not been examined in adequate randomized control trials (RCTs). Both medications are generic and have been available for many years. To convincingly test these medications in patients with severe kidney disease, large, global trials are required. This pilot-phase trial will 1) inform the feasibility and design of a large international trial to evaluate the efficacy and safety of TXA and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery, 2) provide preliminary data regarding the efficacy and safety of TXA and desmopressin in people with advanced kidney disease having noncardiac surgery, and 3) provide pharmacokinetic data to inform dose selection.
Interventions
Treatment arms and agents.
DRUG
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
Placebo
Intravenous 0.9% saline solution
Timeline
From registration to results.
First posted
Mar 29, 2024
Study start
Jun 9, 2025
Primary completion
Feb 2027
Study completion
Jun 2027
Results posted
Not reported
Registry updated
May 22, 2026
Outcomes
What the study measures.
Primary outcomes
Rate of recruitment
Time frame · Through study completion, an average of 1.5 years
A rate of 0.25 patients per study site per week
Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial
Time frame · Day of surgery
Account of whether the patient began to receive study drug for the TXA factorial within an hour before skin incision. Target ≥80% of participants
Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial
Time frame · Day of surgery
Account of whether the patient began to receive study drug for the desmopressin factorial within an hour before skin incision. Target ≥80% of participants
Completion of 30-day follow-up
Time frame · 30 days after randomization
Account of whether the patient or their next-of-kin could be contacted and completed the 30-day post-randomization assessment. Target ≥80% of participants
Secondary outcomes
Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS)
Time frame · 30 days after randomization
Number of patients who experience BIMS
Bleeding Score
Time frame · 30 days after randomization
10-category ordinal score. Minimum scores mean a better outcome. 0 denotes no bleeding or bleeding in which the nadir hemoglobin is ≥70 g/L, no red blood transfusion was given, no reoperation for reasons of bleeding occurred, and there was no death imminently or directly caused by bleeding. 1. denotes bleeding and post-operative hemoglobin \<70 g/L or 1 unit of blood (red blood cells or whole blood) transfused. 2. denotes bleeding and 2 units transfused. 3. denotes bleeding and 3 units transfused. 4. denotes bleeding and 4 units transfused 5. denotes bleeding and 5 units transfused. 6. denotes bleeding and 6 units transfused. 7. denotes bleeding and 7 units transfused. 8. denotes bleeding and 8 or more units of blood transfused. 9. denotes reoperation for reasons of bleeding. 10. denotes death imminently or directly caused by bleeding.
Reoperation for reasons of bleeding
Time frame · 30 days after randomization
Number of patients who return to the operating room for surgical management of suspected documented bleeding
Blood (red blood cells or whole blood) transfused
Time frame · 30 days after randomization
Number of units of blood transfused.
Blood (red blood cells or whole blood) transfused
Time frame · Up to and including postoperative day 3 after surgery
Number of units of blood transfused.
Any blood transfusion (red blood cells or whole blood)
Time frame · 30 days after randomization
Number of units of blood transfused.
Any blood transfusion (red blood cells or whole blood)
Time frame · Up to and including postoperative day 3
Number of units of blood transfused.
Lowest measured hemoglobin concentration
Time frame · 30 days after randomization
The mean absolute difference for continuous outcomes using linear regression with treatment allocation
Most recent hemoglobin concentration
Time frame · 30 days after randomization
The mean absolute difference for continuous outcomes using linear regression with treatment allocation
Death
Time frame · 30 days after randomization
Number of patients who die of any cause
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
3 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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