Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome

NCT ID: NCT05976204

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Congenital Heart Disease Tetralogy of Fallot Neutrophil-lymphocyte Ratio Absolute Lymphocyte Count Thrombocyte-lymphocyte Ratio Outcome TOF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ToF primary repair

Patients who underwent ToF primary repair from January 2020 until December 2022

ToF primary repair

Intervention Type PROCEDURE

ToF primary repair for patients with ToF

Interventions

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ToF primary repair

ToF primary repair for patients with ToF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Sisca Natalia Siagian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sisca N Siagian, MD

Role: PRINCIPAL_INVESTIGATOR

National CCHK

Locations

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National Cardiovascular Center Harapan Kita Jakarta Indonesia

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 40538915 (View on PubMed)

Other Identifiers

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LB.02.01/VII/2023/NLR

Identifier Type: -

Identifier Source: org_study_id

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