Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pro2026000612 | Other Identifier | Rutgers New Jersey Medical School |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid (TXA) | Experimental | Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care. |
|
| Standard of Care (No TXA) | Active Comparator | Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin | Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care. | Baseline to postoperative day 5-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated intraoperative blood loss (milliliters) | Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery. | During surgery |
| Total operative time (minutes) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amjad Alwaal, MD, MSc, FACS | Contact | 973-972-4418 | amjad.alwaal@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amjad Alwaal, MD, MSc, FACS | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22611164 | Result | Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054. | |
| 20554319 | Result | CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14. |
Not provided
Not provided
Individual participant data will not be shared due to institutional policies and the absence of a formal data sharing plan at this time.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| D014522 | Urethral Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Urethroplasty | Procedure | Surgical urethral reconstruction performed according to standard institutional techniques. |
|
Operative time in minutes, defined as time from surgical incision to skin closure completion, as documented in the operative report.
| 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. | During surgery |
| 30-day postoperative complications | Postoperative complications, including bleeding-related events. | Within 30 days after surgery |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |