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

NCT07194304 | Completed Early Phase 1

• 1 other identifier: KET-273/UN2.F1/ETIK/PPM.00.02/
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Keywords

TOF; alpha-tocopherol; cardiac surgery; troponin I

Outcome Measures

Primary Outcomes (1)

• Change in Serum Troponin I Concentration (ng/L)

  Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.

  Before surgery, 1 hour after surgery, and 8 hours after surgery

Secondary Outcomes (10)

• Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)

  Before surgery, 1 hour after surgery, and 8 hours after surgery

• Change in Serum Lactate Concentration (mmol/L)

  Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery

• Myocardial Injury Score (Histopathology, Scale 0-3)

  15 minutes after release of the aortic cross-clamp

• Apoptotic Index (% of Apoptotic Cardiomyocytes)

  tissue sample is collected 15 minutes after releasing the aortic cross clamp

• Duration of Mechanical Ventilation (hours)

  From end of surgery until extubation

Study Arms (2)

alpha-tocopherol

EXPERIMENTAL

assigned to receive either parenteral alpha-tocopherol (4 mg/kg)

Drug: alpha-Tocopherol

sterile water for injection

PLACEBO COMPARATOR

the control group received a placebo (sterile water for injection/aquabidest)

Drug: Sterile Water for Injection

Interventions

alpha-Tocopherol DRUG

patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight

alpha-tocopherol

Sterile Water for Injection DRUG

the control group received a placebo (sterile water for injection/aquabidest)

sterile water for injection

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

alpha-Tocopherol; Injections

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiothoracic Surgeon

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: September 26, 2025
• Study Start: May 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)