xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05976204</url>
    </required_header>
    <id_info>
      <org_study_id>LB.02.01/VII/2023/NLR</org_study_id>
      <nct_id>NCT05976204</nct_id>
    </id_info>
    <brief_title>Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cardiovascular Center Harapan Kita Hospital Indonesia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cardiovascular Center Harapan Kita Hospital Indonesia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which&#xD;
        increases the risk of exacerbated inflammatory response in ToF primary repair. Various&#xD;
        studies have recently shown inflammatory biomarkers to predict morbidity and mortality in&#xD;
        hypoxemic patients, but they are not readily available and expensive.This study aims to&#xD;
        compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count&#xD;
        (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This&#xD;
        was a retrospective observational study on ToF primary repair in National Cardiovascular&#xD;
        Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR&#xD;
        were derived from blood test obtained &lt;14 days before surgery. The primary endpoints were&#xD;
        redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital&#xD;
        length of stay (HLOS) and postoperative LOS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in&#xD;
        National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The&#xD;
        preoperative demographic data included were patients' gender, age, weight, oxygen saturation,&#xD;
        and associated diagnosis other than ToF. The preoperative data of complete blood count and&#xD;
        differential count must be tested from the most recent peripheral blood samples taken no&#xD;
        later than 14 days before the surgery. The data obtained were the number of days of the most&#xD;
        recent blood test including the leukocyte count, percentage neutrophil, percentage and&#xD;
        absolute lymphocyte count, thrombocyte count, as well as the derived variables such as&#xD;
        neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The&#xD;
        intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic&#xD;
        cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and&#xD;
        followed-up for any complications and postoperative mortality during the same hospital stay&#xD;
        until discharge. Patients were then followed up for any cause of mortality within 30 days&#xD;
        postoperative.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Patients Requiring Redo surgery</measure>
      <time_frame>From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first</time_frame>
      <description>Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>Until 30 days postoperative</time_frame>
      <description>Mortality intraoperative or postoperative</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complications (categorized as mild, moderate, severe)</measure>
      <time_frame>From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first</time_frame>
      <description>Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hospital Length of Stay</measure>
      <time_frame>From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first</time_frame>
      <description>Hospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Length of Stay</measure>
      <time_frame>From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first</time_frame>
      <description>Longer postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">501</enrollment>
    <condition>Congenital Heart Disease</condition>
    <condition>Tetralogy of Fallot</condition>
    <condition>Neutrophil-lymphocyte Ratio</condition>
    <condition>Absolute Lymphocyte Count</condition>
    <condition>Thrombocyte-lymphocyte Ratio</condition>
    <condition>Outcome</condition>
    <condition>TOF</condition>
    <arm_group>
      <arm_group_label>ToF primary repair</arm_group_label>
      <description>Patients who underwent ToF primary repair from January 2020 until December 2022</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ToF primary repair</intervention_name>
      <description>ToF primary repair for patients with ToF</description>
      <arm_group_label>ToF primary repair</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients who underwent ToF primary repair in National Cardiovascular Center Harapan Kita&#xD;
          between Januari 2020 until December 2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with ToF and any other associated cardiac anomalies, who underwent ToF&#xD;
               primary repair and had a complete blood cell count with differential count available&#xD;
               preoperatively&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Surgery other than ToF primary repair&#xD;
  &#xD;
            -  Association with other procedures (except patent ductus arteriosus/PDA ligation,&#xD;
               patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries&#xD;
               enlargement)&#xD;
  &#xD;
            -  Preoperative hemodynamic instability&#xD;
  &#xD;
            -  Suspected or confirmed infection with prior antibiotic administration during the same&#xD;
               hospital admission&#xD;
  &#xD;
            -  Absence of complete blood count with differential count&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Sisca N Siagian, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National CCHK</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Cardiovascular Center Harapan Kita Jakarta Indonesia</name>
        <address>
          <city>Jakarta</city>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Cardiovascular Center Harapan Kita Hospital Indonesia</investigator_affiliation>
      <investigator_full_name>Sisca Natalia Siagian</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Congenital Heart Disease</keyword>
    <keyword>Tetralogy of Fallot</keyword>
    <keyword>Neutrophil-lymphocyte ratio</keyword>
    <keyword>Absolute lymphocyte count</keyword>
    <keyword>Thrombocyte-lymphocyte ratio</keyword>
    <keyword>Outcome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Tetralogy of Fallot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>At the moment, the investigators have no plan to share the whole participant data. However, if it is needed, the investigators will</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05976204
  org study id: LB.02.01/VII/2023/NLR
  nct id: NCT05976204
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Retrospective
  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
  description: Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
  measure: Mortality
  time frame: Until 30 days postoperative
  description: Mortality intraoperative or postoperative
  measure: 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
  description: Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.
  measure: 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
  description: Hospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge.
  measure: 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
  description: Longer postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center).
  arm group label: ToF primary repair
  description: Patients who underwent ToF primary repair from January 2020 until December 2022
  intervention type: Procedure
  intervention name: ToF primary repair
  description: ToF primary repair for patients with ToF
  arm group label: ToF primary repair
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  last name: Sisca N Siagian, MD
  role: Principal Investigator
  affiliation: National CCHK
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
  investigator full name: Sisca Natalia Siagian
  investigator title: Principal Investigator
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  mesh term: Tetralogy of Fallot
  sharing ipd: No
  ipd description: At the moment, the investigators have no plan to share the whole participant data. However, if it is needed, the investigators will