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

NCT07778992 | Active Not Recruiting DMC

• 1 other identifier: 1218/2/26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Surgical field visibility

  INTRAOPERATIVE

• Surgeon satisfaction with the surgical field visibility

  INTRAOPERATIVE

• Total operative time

  INTRAOPERATIVE

• Incidence of postoperative bleeding complications

  within 7 days of surgery.

Study Arms (2)

CONTROL GROUP

PLACEBO COMPARATOR

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)

Intervention Group (TXA)

EXPERIMENTAL

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)

Interventions

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)

Intervention Group (TXA)

Control (Normal saline) DRUG

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.

CONTROL GROUP

Eligibility Criteria

• Age: 1 Year - 10 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Anesthesia

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 21, 2026
• Study Start: March 1, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)