Tranexamic Acid + Desmopressin for Reducing Surgical Bleeding

(BRACKETS Trial)

Overseen By Ingrid Copland

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hamilton Health Sciences Corporation

Must not be taking: Prophylactic TXA, Desmopressin

Disqualifiers: Cardiac surgery, Seizure disorder, Stroke, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Pavel Roshanov, MC,MSc,FRCPC

Principal Investigator

Western University

Are You a Good Fit for This Trial?

The BRACKETS pilot trial is for patients with severe kidney problems who are planning noncardiac surgery. They must have very low kidney function or be on dialysis, and they're expected to stay in the hospital overnight after surgery. Participants need to give informed consent.

Inclusion Criteria

I am scheduled for a surgery that is not related to the heart.

Informed consent is obtained to participate in the BRACKETS-Pilot Trial

Included in the TXA factorial

Exclusion Criteria

I am scheduled for heart surgery.

Previously enrolled in the BRACKETS-Pilot Trial

Hypersensitivity or known allergy to TXA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Administration

Participants receive preoperative prophylactic intravenous tranexamic acid or desmopressin, or placebo, within 20 minutes preceding anticipated skin incision

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for safety and effectiveness, including assessment of various outcomes such as bleeding, stroke, and other complications

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Desmopressin
• Tranexamic Acid

Trial Overview This study tests if giving tranexamic acid (TXA) or desmopressin before surgery can reduce bleeding in patients with acute or chronic kidney issues. It's a randomized trial where some get TXA, others get desmopressin, and there's also a placebo group.

How Is the Trial Designed?

Group I: Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. Experimental Treatment 2 Interventions

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.

Group II: Prophylactic intravenous tranexamic acid and placebo. Experimental Treatment 2 Interventions

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.

Group III: Prophylactic intravenous desmopressin and placebo. Experimental Treatment 2 Interventions

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.

Group IV: Placebo and placebo. Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+