Recruiting
Phase 3

TXA, Desmopressin

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06337838

Conditions

Chronic Kidney Diseases

Acute Kidney Injury

Bleeding

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Desmopressin Injectable Solution

Tranexamic Acid Injectable Product

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Diseases

Acute Kidney Injury

Bleeding

Surgery

Study ID

NCT06337838

Start date

Jun 9, 2025

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin.

Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.

Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin intervention group will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes.

experimental: Prophylactic intravenous tranexamic acid and placebo.

Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with eGFR <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.

Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes.

experimental: Prophylactic intravenous desmopressin and placebo.

Within 20 minutes preceding anticipated skin incision, patients will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. Patients will not receive prophylactic tranexamic acid.

Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group.

placebo comparator: Placebo and placebo.

Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group.

Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes.

Interventions

Desmopressin Injectable Solution

Intravenous desmopressin, 20 mcg, single dose administration.

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.

Placebo

Intravenous 0.9% saline solution

Primary outcome measure

  • Rate of recruitment [ Time Frame: 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 [ Time Frame: Day of surgery ]
  • Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial [ Time Frame: Day of surgery ]
  • Completion of 30-day follow-up [ Time Frame: 30 days after randomization ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Principal Investigator:

Pavel Roshanov, MD

McGill University University Health Centre

Recruiting

Montreal, Quebec, Canada, H3H 2R9

Principal Investigator:

Shaifali Sandal, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Major Noncardiac Surgery
  • Tranexamic Acid
  • Desmopressin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-05-22.