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Clinical Trial NCT07501884 (REDUCER) for Urethral Stricture, Urethral Diseases is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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REDUCER Trial (TXA in Urethroplasty) Phase 4 40

Not yet recruiting
Clinical Trial NCT07501884 (REDUCER) is designed to study Treatment for Urethral Stricture, Urethral Diseases. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on May 1, 2026 until the study accrues 40 participants. Led by Amjad Alwaal, MD, MSc, FRCSC, FACS, this study is expected to complete by March 30, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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.
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. Par...

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Official Title

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

Conditions
Urethral StrictureUrethral Diseases
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • REDUCER
  • Pro2026000612
  • Pro2026000612 (Other Identifier) (Rutgers New Jersey Medical School)
NCT ID Number
NCT07501884
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-03-30
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Tranexamic Acid
Urethroplasty
Blood Loss
Hemoglobin
Reconstructive Urology
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTranexamic Acid (TXA)
Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.
Tranexamic Acid
Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
Active ComparatorStandard of Care (No TXA)
Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.
Urethroplasty
Surgical urethral reconstruction performed according to standard institutional techniques.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in hemoglobin
Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care.
Baseline to postoperative day 5-7
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Estimated intraoperative blood loss (milliliters)
Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery.
During surgery
Total operative time (minutes)
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
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
Postoperative complications, including bleeding-related events.
Within 30 days after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • Adult patients (≥18 years old)
  • Undergoing urethroplasty for urethral stricture disease
  • Ability to provide informed consent

  • 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
Amjad Alwaal, MD, MSc, FRCSC, FACS logoAmjad Alwaal, MD, MSc, FRCSC, FACS
Study Responsible Party
Amjad Alwaal, MD, MSc, FRCSC, FACS, Sponsor-Investigator, Associate Professor of Urology, Rutgers, The State University of New Jersey
Study Central Contact
Contact: Amjad Alwaal, MD, MSc, FACS, 973-972-4418, [email protected]
1 Study Locations in 1 Countries

New Jersey

University Hospital, Newark, New Jersey, 07103, United States
Amjad Alwaal, MD, Contact, 973-972-4418, [email protected]