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Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Sponsor: Aswan University Hospital
Summary
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
Official title: Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair - A Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
1 Year - 10 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-03-01
Completion Date
2026-10-01
Last Updated
2026-08-21
Healthy Volunteers
No
Interventions
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)
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.
Locations (1)
Aswan University Hospital
Aswān, Egypt