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

NCT05976204 | Completed

• 1 other identifier: LB.02.01/VII/2023/NLR
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  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

  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

  From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first

Study Arms (1)

ToF primary repair

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

Procedure: ToF primary repair

Interventions

ToF primary repair PROCEDURE

ToF primary repair for patients with ToF

ToF primary repair

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita Jakarta Indonesia

Jakarta, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 40538915 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

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

Study Officials

• Sisca N Siagian, MD

  National CCHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 4, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)