Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.

Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair - A Randomized Controlled Trial

This study aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care

Study Overview

• Status: Active, not recruiting
• Conditions: Perioperative Bleeding During Recurrent Hypospadias Repair
• Intervention / Treatment: Drug: Control (Normal saline); Drug: single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswān, Egypt
    • Aswan university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II.

Exclusion Criteria:

Known personal or family history of bleeding disorders or thrombophilia. Documented history of seizures or epilepsy. Known allergy or hypersensitivity to tranexamic acid. Concurrent use of anticoagulant medications or other antifibrinolytics. Significant renal impairment (eGFR < 60 mL/min/1.73m²).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CONTROL GROUP; Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy	Drug: Control (Normal saline); Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy. It will be administered intravenously in the same manner and over the same duration as the intervention drug to maintain blinding.
Experimental: Intervention Group (TXA); single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)	Drug: single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg); single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative blood loss	This will be quantified using the gravimetric method. All surgical sponges and gauzes will be weighed before use and after being soaked with blood. The difference in weight (1 gram = 1 mL of blood) will be summed to calculate the total blood loss. Suctioned fluids will be measured, and the amount of irrigation fluid used will be subtracted to determine the volume of blood loss collected via suction.	INTRAOPERATIVE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical field visibility	Assessed intraoperatively by the primary surgeon at predefined intervals using the Fromme scale (also known as the Boezaart scale), a validated 5-point scale ranging from 0 (no bleeding) to 4 (severe bleeding, surgery not possible).	INTRAOPERATIVE
Surgeon satisfaction with the surgical field visibility	To be assessed post- operatively using a 5-point Likert scale (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied).	INTRAOPERATIVE
Total operative time	Measured in minutes from the time of skin incision to the application of the final dressing.	INTRAOPERATIVE
Incidence of postoperative bleeding complications	Defined as the occurrence of a clinically significant hematoma (requiring drainage or causing wound compromise) or other bleeding event requiring intervention within 7 days of surgery.	within 7 days of surgery.

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 8, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: 1218/2/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No