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

NCT07778992 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-08-21

No results posted yet for this study

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

Conditions

  • Perioperative Bleeding During Recurrent Hypospadias Repair

Interventions

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)

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.

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778992 on ClinicalTrials.gov