Status:
COMPLETED
Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
Lead Sponsor:
Dr Cipto Mangunkusumo General Hospital
Conditions:
Tetralogy of Fallot (TOF)
Alpha-tocopherol
Eligibility:
All Genders
1-10 years
Phase:
EARLY_PHASE1
Brief Summary
Introduction: Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxi...
Eligibility Criteria
Inclusion
- Diagnosis of congenital heart disease Tetralogy of Fallot (ToF)
- Age between 1 and 10 years
- Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM
Exclusion
- History of prior palliative surgery (e.g., Blalock-Taussig shunt)
- Presence of additional congenital heart disease requiring major modification or addition of surgical procedures
- History of central nervous system disorder or stroke
- History of cardiopulmonary resuscitation (CPR)
- Undergoing redo surgery (e.g., residual stenosis, bleeding)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07194304
Start Date
May 1 2022
End Date
June 1 2025
Last Update
September 26 2025
Active Locations (1)
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1
Cipto Mangunkusumo Hospital
Jakarta, Indonesia