REDUCER Trial (TXA in Urethroplasty)

NCT07501884 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro2026000612
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urethral Stricture; Urethral Diseases

Keywords

Tranexamic Acid; Urethroplasty; Blood Loss; Hemoglobin; Reconstructive Urology

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

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

  Baseline to postoperative day 5-7

Secondary Outcomes (4)

• Estimated intraoperative blood loss (milliliters)

  During surgery

• Total operative time (minutes)

  During surgery

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

  During surgery

• 30-day postoperative complications

  Within 30 days after surgery

Study Arms (2)

Tranexamic Acid (TXA)

EXPERIMENTAL

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

Drug: Tranexamic Acid

Standard of Care (No TXA)

ACTIVE COMPARATOR

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

Procedure: Urethroplasty

Interventions

Tranexamic Acid DRUG

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

Tranexamic Acid (TXA)

Urethroplasty PROCEDURE

Surgical urethral reconstruction performed according to standard institutional techniques.

Standard of Care (No TXA)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amjad Alwaal, MD, MSc, FRCSC, FACS: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (2)

• Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.

  PMID: 22611164 RESULT

• CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

  PMID: 20554319 RESULT

MeSH Terms

Conditions

Urethral Stricture; Urethral Diseases; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amjad Alwaal, MD, MSc, FACS

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amjad Alwaal, MD, MSc, FACS

CONTACT

973-972-4418; amjad.alwaal@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: Participants will be randomized in a 1:1 ratio to receive either tranexamic acid (TXA) or standard of care without TXA. Allocation will occur prior to surgery. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two parallel groups.

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)