Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study
Amjad Alwaal, MD, MSc, FRCSC, FACS
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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
Interventions
- DrugTranexamic Acid
Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
- ProcedureUrethroplasty
Surgical urethral reconstruction performed according to standard institutional techniques.
Location
- University HospitalNewark, New Jersey