Trial · NCT07194304
Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
NCT07194304, Early phase 1, Completed, Dr Cipto Mangunkusumo General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot. Trials, record NCT07194304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07194304
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
- NCT number
- NCT07194304
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Conditions
- Tetralogy of Fallot (TOF), Alpha-tocopherol, Cardiac Surgery
- Interventions
- alpha-Tocopherol, Sterile Water for Injection
- First posted
- 2025-09-26
- Last updated
- 2025-09-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Troponin I Concentration (ng/L) | Before surgery, 1 hour after surgery, and 8 hours after surgery | 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. |
| Secondary | Change in Serum Malondialdehyde (MDA) Concentration (ng/mL) | Before surgery, 1 hour after surgery, and 8 hours after surgery | Serum malondialdehyde (MDA), a biomarker of oxidative stress, will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to evaluate oxidative injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair. |
| Secondary | Change in Serum Lactate Concentration (mmol/L) | Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery | Serum lactate levels will be measured at baseline (before surgery), and at 1 hour, 6 hours, 12 hours, and 24 hours after surgery to evaluate tissue perfusion and metabolic response associated with cardiopulmonary bypass during Tetralogy of Fallot repair. |
| Secondary | Myocardial Injury Score (Histopathology, Scale 0-3) | 15 minutes after release of the aortic cross-clamp | Myocardial tissue injury will be assessed from biopsy samples collected 15 minutes after release of the aortic cross-clamp. Injury will be graded on a histopathological scale ranging from 0 to 3, where 0 = no injury and 3 = severe injury. Higher scores indicate worse myocardial damage. |
| Secondary | Apoptotic Index (% of Apoptotic Cardiomyocytes) | tissue sample is collected 15 minutes after releasing the aortic cross clamp | The apoptotic index will be calculated from myocardial tissue samples collected 15 minutes after release of the aortic cross-clamp. Sections are stained with TUNEL and examined at 40× magnification across 6 hotspot areas. The index is expressed as the percentage of TUNEL-positive cardiomyocytes per 100 cardiomyocytes. The scale ranges from 0% (no apoptosis) to 100% (all cells apoptotic). Higher values indicate greater myocardial apoptosis. |
| Secondary | Duration of Mechanical Ventilation (hours) | From end of surgery until extubation | Duration of postoperative mechanical ventilation will be recorded in hours. |
| Secondary | anti-cTnI | tissue sample is collected 15 minutes after releasing the aortic cross clamp | |
| Secondary | GPx expression | tissue sample is collected 15 minutes after releasing the aortic cross clamp | |
| Secondary | Intensive Care Unit Length of Stay (days) | From ICU admission until ICU discharge, assessed up to 14 days | ICU length of stay will be recorded in days from ICU admission until ICU discharge. |
| Secondary | Hospital Length of Stay (days) | From hospital admission until hospital discharge, assessed up to 30 days | Hospital length of stay will be recorded in days from hospital admission until discharge. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07194304
GET https://conductscience.org/api/trials/v1/NCT07194304/registered