Congenital Heart DiseaseNCT05976204
Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome
An observational study of Congenital Heart Disease and Tetralogy of Fallot, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte Ratio
- What is being tested?
- ToF primary repair
- Type of treatment
- Surgery or procedure
- How many people
- 501 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: patients who underwent ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022
Who may be able to join
- All patients with ToF and any other associated cardiac anomalies, who underwent ToF primary repair and had a complete blood cell count with differential count available preoperatively
Who cannot join
- Surgery other than ToF primary repair
- Association with other procedures (except patent ductus arteriosus/PDA ligation, patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries enlargement)
- Preoperative hemodynamic instability
- Suspected or confirmed infection with prior antibiotic administration during the same hospital admission
- Absence of complete blood count with differential count
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Jakarta Indonesia
Jakarta
About this study
Official title: Prognostic Value of Neutrophil-Lymphocyte Ratio (NLR), Absolute Lymphocyte Count (ALC), and Thrombocyte-Lymphocyte Ratio (TLR) in Predicting the Outcomes of Tetralogy of Fallot Primary Repair
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.
Read the detailed description
This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The preoperative demographic data included were patients' gender, age, weight, oxygen saturation, and associated diagnosis other than ToF. The preoperative data of complete blood count and differential count must be tested from the most recent peripheral blood samples taken no later than 14 days before the surgery. The data obtained were the number of days of the most recent blood test including the leukocyte count, percentage neutrophil, percentage and absolute lymphocyte count, thrombocyte count, as well as the derived variables such as neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and followed-up for any complications and postoperative mortality during the same hospital stay until discharge. Patients were then followed up for any cause of mortality within 30 days postoperative.
- Conditions
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte Ratio, Absolute Lymphocyte Count, Thrombocyte-lymphocyte Ratio, Outcome
- Being tested
- ToF primary repair
- Keywords
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte ratio, Absolute lymphocyte count, Thrombocyte-lymphocyte ratio, Outcome
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToF primary repairProcedure or surgery
ToF primary repair for patients with ToF
| Study group | Role | What they receive |
|---|---|---|
| ToF primary repair | Patients who underwent ToF primary repair from January 2020 until December 2022 Receives: Procedure: ToF primary repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Redo surgery
Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
Measured: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Mortality
Mortality intraoperative or postoperative
Measured: Until 30 days postoperative
Complications (categorized as mild, moderate, severe)
Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.
Measured: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Secondary outcomes (2)
Hospital Length of Stay
Hospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge.
Measured: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Postoperative Length of Stay
Longer postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center).
Measured: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sisca Natalia Siagian, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Sisca N Siagian, MD, Principal investigator, National CCHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976204
- Sponsor's protocol ID
- LB.02.01/VII/2023/NLR
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment, the investigators have no plan to share the whole participant data. However, if it is needed, the investigators will
Publications
Siagian SN, Christianto C. Prognostic value of neutrophil-lymphocyte ratio, absolute lymphocyte count, and thrombocyte-lymphocyte ratio in predicting the outcomes of tetralogy of fallot primary repair. Front Cardiovasc Med. 2025 Jun 5;12:1489242. doi: 10.3389/fcvm.2025.1489242. eCollection 2025.
PubMed 40538915
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Neutrophil-Lymphocyte Ratio (NLR), Absolute Lymphocyte Count (ALC), and Thrombocyte-Lymphocyte Ratio (TLR) in Predicting the Outcomes of Tetralogy of Fallot Primary Repair
- ClinicalTrials.gov ID
- NCT05976204
- Acronym / sponsor ID
- LB.02.01/VII/2023/NLR
- Conditions
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte Ratio, Absolute Lymphocyte Count, Thrombocyte-lymphocyte Ratio, Outcome
- Keywords
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte ratio, Absolute lymphocyte count, Thrombocyte-lymphocyte ratio, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.
Detailed description
This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The preoperative demographic data included were patients' gender, age, weight, oxygen saturation, and associated diagnosis other than ToF. The preoperative data of complete blood count and differential count must be tested from the most recent peripheral blood samples taken no later than 14 days before the surgery. The data obtained were the number of days of the most recent blood test including the leukocyte count, percentage neutrophil, percentage and absolute lymphocyte count, thrombocyte count, as well as the derived variables such as neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and followed-up for any complications and postoperative mortality during the same hospital stay until discharge. Patients were then followed up for any cause of mortality within 30 days postoperative.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ToF primary repair | – | Procedure: ToF primary repairPatients who underwent ToF primary repair from January 2020 until December 2022 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients who underwent ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022
Key inclusion criteria (1 listed)
- All patients with ToF and any other associated cardiac anomalies, who underwent ToF primary repair and had a complete blood cell count with differential count available preoperatively
Key exclusion criteria (5 listed)
- Surgery other than ToF primary repair
- Association with other procedures (except patent ductus arteriosus/PDA ligation, patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries enlargement)
- Preoperative hemodynamic instability
- Suspected or confirmed infection with prior antibiotic administration during the same hospital admission
- Absence of complete blood count with differential count
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToF primary repairToF primary repair for patients with ToF | Procedure or surgery | ToF primary repair |
Primary outcome
Number of Patients Requiring Redo surgery
Time frame: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
Mortality
Time frame: Until 30 days postoperative
Mortality intraoperative or postoperative
Complications (categorized as mild, moderate, severe)
Time frame: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.
2 secondary outcomes
Hospital Length of Stay
Time frame: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Postoperative Length of Stay
Time frame: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 40538915Siagian SN, Christianto C. Prognostic value of neutrophil-lymphocyte ratio, absolute lymphocyte count, and thrombocyte-lymphocyte ratio in predicting the outcomes of tetralogy of fallot primary repair. Front Cardiovasc Med. 2025 Jun 5;12:1489242. doi: 10.3389/fcvm.2025.1489242. eCollection 2025.
- Individual participant dataSharing planned: No. At the moment, the investigators have no plan to share the whole participant data. However, if it is needed, the investigators will
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sisca N Siagian, MD principal investigator
National CCHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Tetralogy of Fallot, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Requiring Redo surgery (time frame: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.