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

Dr Cipto Mangunkusumo General Hospital

Status and phase

Completed

Early Phase 1

Conditions

Cardiac Surgery

Tetralogy of Fallot (TOF)

Alpha-tocopherol

Treatments

Drug: Sterile Water for Injection

Drug: alpha-Tocopherol

Study type

Interventional

Funder types

Other

Identifiers

NCT07194304

KET-273/UN2.F1/ETIK/PPM.00.02/

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)