REDUCER Trial (TXA in Urethroplasty) (REDUCER)

March 25, 2026 updated by: Amjad Alwaal, MD, MSc, FRCSC, FACS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid (TXA)
Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.
Drug: Tranexamic Acid
Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
Active Comparator: Standard of Care (No TXA)
Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.
Procedure: Urethroplasty
Surgical urethral reconstruction performed according to standard institutional techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to postoperative day 5-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During surgery
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.
During surgery
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.
During surgery
30-day postoperative complications
Time Frame: Within 30 days after surgery
Postoperative complications, including bleeding-related events.
Within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amjad Alwaal, MD, MSc, FRCSC, FACS

Investigators

  • Principal Investigator: Amjad Alwaal, MD, MSc, FACS, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2026000612 (Other Identifier: Rutgers New Jersey Medical School)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies and the absence of a formal data sharing plan at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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