NCT07501884

REDUCER Trial (TXA in Urethroplasty)

Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Amjad Alwaal, MD, MSc, FRCSC, FACS · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty. Participants will be randomly assigned to receive either a single intravenous dose of TXA at the start of anesthesia or standard care without TXA. Researchers will compare hemoglobin change after surgery as well as estimated blood loss and complications.

Detailed description

Urethroplasty can be associated with variable perioperative blood loss. Tranexamic acid (TXA) is an antifibrinolytic medication that has been shown to reduce blood loss in multiple surgical settings, but it has not been well studied in urethroplasty. This is a prospective, randomized, open-label trial evaluating the effect of a single perioperative dose of TXA in adult patients undergoing elective urethroplasty. Participants will be assigned in a 1:1 ratio to receive either TXA or standard care without TXA. TXA will be administered as a single intravenous dose at induction of anesthesia. The primary outcome is postoperative change in hemoglobin. Secondary outcomes include estimated blood loss, operative time, transfusion requirement, and perioperative complications. Participants will be followed through the postoperative period, including routine clinical follow-up. Study data will be collected from routine clinical care and the electronic medical record. The goal of this study is to determine whether TXA may provide a simple and practical strategy to reduce blood loss in urethroplasty.

Conditions

• Urethral Stricture
• Urethral Diseases

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
PROCEDURE	Urethroplasty	Surgical urethral reconstruction performed according to standard institutional techniques.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2027-03-30
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study