<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/NCT03007108</url>
  </required_header>
  <id_info>
    <org_study_id>PO16107</org_study_id>
    <nct_id>NCT03007108</nct_id>
  </id_info>
  <brief_title>Age-dependency of Thrombin Generation Using a New Standardized Assay</brief_title>
  <acronym>TGT</acronym>
  <official_title>Determination of Normal Range Values of Thrombin Generation Parameters in Pediatrics Population Using a New Standardized Thrombin Generation Assay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <brief_summary>
    <textblock>
      The aim of this study is to establish normal values of thrombin generation assay parameters&#xD;
      in pediatrics, according to different age groups. The standardized thrombin generation assay&#xD;
      &quot;Genesia™&quot; will be used. Different age groups of healthy children will be recruited :&#xD;
      neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15&#xD;
      years old. Adults values will be obtained (healthy adults &gt; 18 years old).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Materials and Methods Collection of blood samples Blood samples of 240 healthy children will&#xD;
      be obtained from the blood that will be collected for the routine coagulation screening (in&#xD;
      neonates and in children &lt; 18 months) or at the time of surgery in children aged &gt; 18 months.&#xD;
      Healthy neonates will be recruited by the neonatologists. Children aged from 1 month to 15&#xD;
      years will be included by anesthesiologists before minor elective surgery such as&#xD;
      tonsillectomy, adenoidectomy, phimosis or oral surgery. Additionally, blood from adults&#xD;
      referred for thrombophilia testing will be studied. This study was approved by French&#xD;
      authorities (ANSM and CPP). Inform consent will be obtained from all participants. Blood will&#xD;
      be collected into plastic tubes containing sodium citrate (0.106 M, tubes from &quot;Starstedt&quot;).&#xD;
      Platelet poor plasma will be obtained by two centrifugations for 10 minutes at 2500 g at room&#xD;
      temperature and stored at - 70°C until further examination.&#xD;
&#xD;
      Statistical analysis Statistical analysis will be performed as 1) a descriptive analysis&#xD;
      (frequency and percentage for qualitative data, mean, SD and centiles for quantitative data),&#xD;
      and 2) a comparison analysis (student, Mann-Withney, Kruskall- Wallis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thrombin generation</measure>
    <time_frame>Day 0</time_frame>
    <description>The standardized thrombin generation assay Genesia™ will be used</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Healthy Infants</condition>
  <arm_group>
    <arm_group_label>healthy infants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood withdrawal</intervention_name>
    <arm_group_label>healthy infants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent from parents of children&#xD;
&#xD;
          -  Informed consent from patients in the case of adults refered for thrombophilia testing&#xD;
&#xD;
          -  Affiliation to the French Health Social System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  weight &lt; 3250 g&#xD;
&#xD;
          -  Patients under law protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03007108
org study id: PO16107
nct id: NCT03007108
lead sponsor: 
The aim of this study is to establish normal values of thrombin generation assay parameters
      in pediatrics, according to different age groups. The standardized thrombin generation assay
      "Genesia™" will be used. Different age groups of healthy children will be recruited :
      neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15
      years old. Adults values will be obtained (healthy adults > 18 years old).
Materials and Methods Collection of blood samples Blood samples of 240 healthy children will
      be obtained from the blood that will be collected for the routine coagulation screening (in
      neonates and in children < 18 months) or at the time of surgery in children aged > 18 months.
      Healthy neonates will be recruited by the neonatologists. Children aged from 1 month to 15
      years will be included by anesthesiologists before minor elective surgery such as
      tonsillectomy, adenoidectomy, phimosis or oral surgery. Additionally, blood from adults
      referred for thrombophilia testing will be studied. This study was approved by French
      authorities (ANSM and CPP). Inform consent will be obtained from all participants. Blood will
      be collected into plastic tubes containing sodium citrate (0.106 M, tubes from "Starstedt").
      Platelet poor plasma will be obtained by two centrifugations for 10 minutes at 2500 g at room
      temperature and stored at - 70°C until further examination.

      Statistical analysis Statistical analysis will be performed as 1) a descriptive analysis
      (frequency and percentage for qualitative data, mean, SD and centiles for quantitative data),
      and 2) a comparison analysis (student, Mann-Withney, Kruskall- Wallis).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Thrombin generation
time frame: Day 0
description: The standardized thrombin generation assay Genesia™ will be used
arm group label: healthy infants
arm group type: Experimental
intervention type: Other
intervention name: blood withdrawal
arm group label: healthy infants
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor