Urethral Stricture, Urethral Diseases
Conditions
Keywords
Tranexamic Acid, Urethroplasty, Blood Loss, Hemoglobin, Reconstructive Urology
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. 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.
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.
Sponsors
Amjad Alwaal, MD, MSc, FRCSC, FACS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either tranexamic acid (TXA) or standard of care without TXA. Allocation will occur prior to surgery. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two parallel groups.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin | Baseline to postoperative day 5-7 | Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated intraoperative blood loss (milliliters) | During surgery | Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery. |
| Total operative time (minutes) | During surgery | Operative time in minutes, defined as time from surgical incision to skin closure completion, as documented in the operative report. |
| Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale | During surgery | 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. |
| 30-day postoperative complications | Within 30 days after surgery | Postoperative complications, including bleeding-related events. |
Countries
United States
Contacts
CONTACTAmjad Alwaal, MD, MSc, FACS
PRINCIPAL_INVESTIGATORAmjad Alwaal, MD, MSc, FACS
Rutgers University
Outcome results
None listed