Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
NCT ID: NCT07194304
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2022-05-01
2025-06-01
Brief Summary
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Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery.
Methods:
This randomized controlled trial included 58 ToF patients aged 1-10 years undergoing definitive surgery with CPB at Integrated Heart Center, Cipto Mangunkusumo Hospital. Patients were randomly assigned to receive either parenteral alpha-tocopherol (4 mg/kg) or placebo at the initiation of CPB. The primary outcome was postoperative troponin I level.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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alpha-tocopherol
assigned to receive either parenteral alpha-tocopherol (4 mg/kg)
alpha-Tocopherol
patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight
sterile water for injection
the control group received a placebo (sterile water for injection/aquabidest)
Sterile Water for Injection
the control group received a placebo (sterile water for injection/aquabidest)
Interventions
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alpha-Tocopherol
patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight
Sterile Water for Injection
the control group received a placebo (sterile water for injection/aquabidest)
Eligibility Criteria
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Inclusion Criteria
* Age between 1 and 10 years
* Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM
Exclusion Criteria
* 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)
1 Year
10 Years
ALL
No
Sponsors
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Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Suprayitno Wardoyo
Consultant Cardiothoracic Surgeon
Locations
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Cipto Mangunkusumo Hospital
Jakarta, , Indonesia
Countries
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Other Identifiers
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KET-273/UN2.F1/ETIK/PPM.00.02/
Identifier Type: -
Identifier Source: org_study_id
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