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REDUCER Trial (TXA in Urethroplasty)

ConditionsUrethral StrictureUrethral Diseases
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmjad Alwaal, MD, MSc, FRCSC, FACS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years old)

Undergoing urethroplasty for urethral stricture disease

Ability to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid

    Drug

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

  • Urethroplasty

    Procedure/Surgery

    Surgical urethral reconstruction performed according to standard institutional techniques.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Tranexamic Acid (TXA)Experimental treatment 1 intervention
Group B: Standard of Care (No TXA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in hemoglobin

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

Time frame
Baseline to postoperative day 5-7

Secondary outcomes

1

Estimated intraoperative blood loss (milliliters)

Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery.

Time frame
During surgery
2

Total operative time (minutes)

Operative time in minutes, defined as time from surgical incision to skin closure completion, as documented in the operative report.

Time frame
During surgery
3

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.

Time frame
During surgery
4

30-day postoperative complications

Postoperative complications, including bleeding-related events.

Time frame
Within 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amjad Alwaal, MD, MSc, FRCSC, FACS

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: