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NCT Number: NCT07501884

REDUCER Trial (TXA in Urethroplasty)

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.

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.

Urethroplasty

Procedure

Surgical urethral reconstruction performed according to standard institutional techniques.

Primary outcomes

  1. Change in hemoglobin

    Time frame: Baseline to postoperative day 5-7

    Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care.

Secondary outcomes

  1. Estimated intraoperative blood loss (milliliters)

    Time frame: During surgery

    Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery.

  2. Total operative time (minutes)

    Time frame: During surgery

    Operative time in minutes, defined as time from surgical incision to skin closure completion, as documented in the operative report.

  3. Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale

    Time frame: During surgery

    Intraoperative surgical field quality will be assessed by the operating surgeon using the Boezaart Surgical Field Grading Scale, a 6-point ordinal scale ranging from 0 to 5, where 0 = no bleeding, 1 = slight bleeding with no suction required, 2 = slight bleeding requiring occasional suction, 3 = slight bleeding requiring frequent suction and threatening the surgical field, 4 = moderate bleeding requiring frequent suction and significantly threatening the surgical field, and 5 = severe bleeding requiring constant suction and making surgery nearly impossible. Higher scores indicate worse operative field quality.

  4. 30-day postoperative complications

    Time frame: Within 30 days after surgery

    Postoperative complications, including bleeding-related events.

Study contacts

Contact information is provided by the study sponsor or research team.

Amjad Alwaal, MD, MSc, FACS

CONTACT

[email protected]

973-972-4418

Sponsors and collaborators

Lead sponsor

Amjad Alwaal, MD, MSc, FRCSC, FACS

Other

Registry information

Official study title

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

Acronym: REDUCER

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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