REDUCER Trial (TXA in Urethroplasty)

Amjad Alwaal, MD, MSc, FRCSC, FACS

Status and phase: Not yet enrolling; Phase 4

Conditions: Urethral Diseases; Urethral Stricture

Treatments: Procedure: Urethroplasty; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT07501884

Pro2026000612 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥18 years old)
• Undergoing urethroplasty for urethral stricture disease
• Ability to provide informed consent

Exclusion criteria

• Known contraindication to tranexamic acid (TXA)
• History of thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke)
• Known bleeding disorder or coagulopathy
• Current use of anticoagulation that cannot be safely held perioperatively
• Severe renal impairment
• Allergy or hypersensitivity to tranexamic acid
• History of seizures
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tranexamic Acid (TXA)

Experimental group

Description:

Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.

Treatment:

Drug: Tranexamic Acid

Standard of Care (No TXA)

Active Comparator group

Description:

Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.

Treatment:

Procedure: Urethroplasty