<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/NCT04456751</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB_redoped</org_study_id>
    <nct_id>NCT04456751</nct_id>
  </id_info>
  <brief_title>Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?</brief_title>
  <official_title>Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In pediatric cardiac surgery, transfusion requirements are associated with age, development&#xD;
      status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac&#xD;
      surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The&#xD;
      investigators want to study if this association is also true in pediatric cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher&#xD;
      transfusion rate, this is not really known in paediatric cardiac surgery. In this&#xD;
      retrospective study, the investigators will analyse our database for paediatric cardiac&#xD;
      surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single&#xD;
      cardiac surgery will be compared to patients with a second cardiac operation under&#xD;
      extracorporeal bypass. The investigators will test the variables for normal distribution&#xD;
      using a Shapiro-Wilk test. Non normal distributed variables will be compared by a&#xD;
      non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A&#xD;
      univariate analysis will determine predicting factors for transfusion. Factors with a P value&#xD;
      &lt; 0.1 will be analysed by a multivariate analysis to determine independent factors for&#xD;
      transfusion. Odds with 95% confidence intervals will be calculated. A P value &lt; 0.05 will be&#xD;
      considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</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>Transfusion of packed red cells (mL/kg)</measure>
    <time_frame>Day of operation up to 5 days postop</time_frame>
    <description>Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2439</enrollment>
  <condition>Pediatric Cardiac Surgery</condition>
  <condition>Transfusion</condition>
  <arm_group>
    <arm_group_label>No redo op</arm_group_label>
    <description>Patients with a single cardiac operation under extracorporeal bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Redo op</arm_group_label>
    <description>Patients with a redo cardiac operation under extracorporeal bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Redo op</intervention_name>
    <description>Patients with a redo operation</description>
    <arm_group_label>Redo op</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass&#xD;
        in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 0 and 16 years&#xD;
&#xD;
          -  Cardiac surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Jehova's witness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Denis Schmartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Universitaire des Enfants Reine Fabiola</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Denis SCHMARTZ</investigator_full_name>
    <investigator_title>Head of Anesthesiology department</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04456751
org study id: CHUB_redoped
nct id: NCT04456751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In pediatric cardiac surgery, transfusion requirements are associated with age, development
      status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac
      surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The
      investigators want to study if this association is also true in pediatric cardiac surgery.
Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher
      transfusion rate, this is not really known in paediatric cardiac surgery. In this
      retrospective study, the investigators will analyse our database for paediatric cardiac
      surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single
      cardiac surgery will be compared to patients with a second cardiac operation under
      extracorporeal bypass. The investigators will test the variables for normal distribution
      using a Shapiro-Wilk test. Non normal distributed variables will be compared by a
      non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A
      univariate analysis will determine predicting factors for transfusion. Factors with a P value
      < 0.1 will be analysed by a multivariate analysis to determine independent factors for
      transfusion. Odds with 95% confidence intervals will be calculated. A P value < 0.05 will be
      considered statistically significant.
observational model: Cohort
time perspective: Retrospective
measure: Transfusion of packed red cells (mL/kg)
time frame: Day of operation up to 5 days postop
description: Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight
arm group label: No redo op
description: Patients with a single cardiac operation under extracorporeal bypass
arm group label: Redo op
description: Patients with a redo cardiac operation under extracorporeal bypass
intervention type: Other
intervention name: Redo op
description: Patients with a redo operation
arm group label: Redo op
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
last name: Denis Schmartz, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Denis SCHMARTZ
investigator title: Head of Anesthesiology department
sharing ipd: No