A Phase 4 interventional study of Tranexamic Acid and Urethroplasty in Urethral Stricture and Urethral Diseases, sponsored by Amjad Alwaal, MD, MSc, FRCSC, FACS. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Amjad Alwaal, MD, MSc, FRCSC, FACS · Phase 4, Interventional, and Treatment
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.
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.
72 studies on the registry are indexed under Urethral Stricture; 25 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 56 interventional studies indexed under Urethral Stricture.
Browse Urethral Stricture studies →This is the only study on the registry with Amjad Alwaal, MD, MSc, FRCSC, FACS as lead sponsor.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.
Drug: Tranexamic Acid
Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.
Procedure: Urethroplasty
Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
Surgical urethral reconstruction performed according to standard institutional techniques.
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
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
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
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
30-day postoperative complications
Postoperative complications, including bleeding-related events.
Time frame: Within 30 days after surgery
Plan to share: No — Individual participant data will not be shared due to institutional policies and the absence of a formal data sharing plan at this time.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid