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

N/AActive Not RecruitingNCT07778992

Aswan University Hospital44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Perioperative Bleeding During Recurrent Hypospadias Repair

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)

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.

Eligibility

Sex: MALEMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

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).

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

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.

Time frame: INTRAOPERATIVE

Secondary Outcomes

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).

Time frame: 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).

Time frame: INTRAOPERATIVE

Total operative time

Measured in minutes from the time of skin incision to the application of the final dressing.

Time frame: 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.

Time frame: within 7 days of surgery.

Data from ClinicalTrials.gov

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