REDUCER Trial (TXA in Urethroplasty)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Urethroplasty.
- Who it may be relevant to
- Registry conditions: Urethral Stricture, Urethral Diseases. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in hemoglobin [Time frame: Baseline to postoperative day 5-7]
Secondary outcome measures (4)
- Estimated intraoperative blood loss (milliliters) [Time frame: During surgery]
- Total operative time (minutes) [Time frame: During surgery]
- Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale [Time frame: During surgery]
- 30-day postoperative complications [Time frame: Within 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Hospital — Newark
Publications
- 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
- 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 bloo PMID 20554319
Identifiers
NCT: NCT07501884 · Pro2026000612 · Pro2026000612