Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

What Was Tested

The trial (phase 3) is built around Desmopressin.

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.

It had four arms (groups): Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. (experimental), Prophylactic intravenous tranexamic acid and placebo. (experimental), Prophylactic intravenous desmopressin and placebo. (experimental) and Placebo and placebo. (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: One of either:. 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.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: undergoing cardiac surgery;; undergoing intracranial neurosurgery;; undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;.

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-06-09 with completion listed for 2027-02.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 46 secondary outcomes, for example Bleeding Score, Reoperation for reasons of bleeding, Blood (red blood cells or whole blood) transfused, Blood (red blood cells or whole blood) transfused, Any blood transfusion (red blood cells or whole blood) and Any blood transfusion (red blood cells or whole blood).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.