NCT07194304

Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Tetralogy of Fallot (TOF)
• Alpha-tocopherol
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	alpha-Tocopherol	patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight
DRUG	Sterile Water for Injection	the control group received a placebo (sterile water for injection/aquabidest)

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-01-01
• Completion: 2025-06-01
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: Indonesia