REDUCER Trial (TXA in Urethroplasty)

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Amjad Alwaal, MD, MSc, FRCSC, FACS
Study ID
NCT07501884
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Urethral Diseases
  • Urethral Stricture

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tranexamic Acid (TXA)
    Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.
  • Active Comparator: Standard of Care (No TXA)
    Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.

Primary Outcome Measure

Change in hemoglobin [ Time Frame: Baseline to postoperative day 5-7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalNewarkNew Jersey07103
Amjad Alwaal, MD
[email protected]
973-972-4418

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By research site
University Hospital· Newark, NJ

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