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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05976204
Enrollment
501
Registered
2023-08-04
Start date
2020-01-01
Completion date
2023-06-30
Last updated
2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte ratio, Absolute lymphocyte count, Thrombocyte-lymphocyte ratio, Outcome

Brief 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 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.

Interventions

PROCEDUREToF primary repair

ToF primary repair for patients with ToF

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Requiring Redo surgeryFrom the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came firstRedo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
MortalityUntil 30 days postoperativeMortality intraoperative or postoperative
Complications (categorized as mild, moderate, severe)From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came firstComplication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.

Secondary

MeasureTime frameDescription
Hospital Length of StayFrom the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came firstHospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge.
Postoperative Length of StayFrom the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came firstLonger postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026