<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/NCT03244332</url>
  </required_header>
  <id_info>
    <org_study_id>2013/06JUI/358</org_study_id>
    <nct_id>NCT03244332</nct_id>
  </id_info>
  <brief_title>HEMOCC Study. Hemostasis in Cirrhotic Children.</brief_title>
  <acronym>HEMOCC</acronym>
  <official_title>HEMOCC Study Hemostasis in Cirrhotic Children : Assessment of Risk Factors of Spontaneous Bleeding From Oesophageal Varices in Cirrhotic Children Waiting for a Graft.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</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>
      Prospective investigations into the role of hemostatic factors in the risk of variceal&#xD;
      bleeding among children with chronic liver disease (thromboelastometry e.g) is still&#xD;
      required. A better understanding of these factors would permit better risk stratification and&#xD;
      targeted prophylaxis or therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to start a prospective and observational study over a 2 years period.&#xD;
&#xD;
      First, the investigators will identify all children suffering from cirrhosis irrespective of&#xD;
      underlying etiology and/or portal hypertension coming into the pediatric&#xD;
      hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or&#xD;
      acquired thrombophilia/haemorrhagic disorder will be excluded. The investigators expect to&#xD;
      include 20 to 30 children in the study.&#xD;
&#xD;
      The investigators will meet the parents to give them explanations about this study and its&#xD;
      implications. Then the investigators will get the free and informed consent about the&#xD;
      participation to this clinical study. Parents are obviously free to refuse to take part in&#xD;
      this clinical study and to retire from it at any moment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2013</start_date>
  <completion_date type="Actual">July 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators aim to start a prospective and observational study over a 2 years period.&#xD;
First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhaegic disorder will be excluded.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions</measure>
    <time_frame>over 2 year period</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Esophageal and Gastric Varices</condition>
  <condition>Child, Only</condition>
  <arm_group>
    <arm_group_label>Decompensated cirrhosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compensated cirrhosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collecting Clinical Data</intervention_name>
    <description>Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)</description>
    <arm_group_label>Compensated cirrhosis</arm_group_label>
    <arm_group_label>Decompensated cirrhosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collecting laboratory data</intervention_name>
    <description>Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.</description>
    <arm_group_label>Compensated cirrhosis</arm_group_label>
    <arm_group_label>Decompensated cirrhosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children suffering from decompensated cirrhosis and needing an orthotopic liver&#xD;
             transplantation&#xD;
&#xD;
          -  Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai&#xD;
             surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis&#xD;
             (portal vein thrombosis e.g)&#xD;
&#xD;
          -  Each patient will have a comprehensive assessment of portal hypertension (abdominal&#xD;
             US-Doppler and upper gastrointestinal endoscopy) and hemostasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No underlying disease which can alter hemostasis (hemophilia, sepsis…)&#xD;
&#xD;
          -  No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Stephenne, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is no plan at this time</ipd_description>
  </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/NCT03244332
org study id: 2013/06JUI/358
nct id: NCT03244332
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective investigations into the role of hemostatic factors in the risk of variceal
      bleeding among children with chronic liver disease (thromboelastometry e.g) is still
      required. A better understanding of these factors would permit better risk stratification and
      targeted prophylaxis or therapy.
The investigators aim to start a prospective and observational study over a 2 years period.

      First, the investigators will identify all children suffering from cirrhosis irrespective of
      underlying etiology and/or portal hypertension coming into the pediatric
      hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or
      acquired thrombophilia/haemorrhagic disorder will be excluded. The investigators expect to
      include 20 to 30 children in the study.

      The investigators will meet the parents to give them explanations about this study and its
      implications. Then the investigators will get the free and informed consent about the
      participation to this clinical study. Parents are obviously free to refuse to take part in
      this clinical study and to retire from it at any moment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The investigators aim to start a prospective and observational study over a 2 years period.
First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhaegic disorder will be excluded.
primary purpose: Prevention
masking: None (Open Label)
measure: To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
time frame: over 2 year period
arm group label: Decompensated cirrhosis
arm group type: Experimental
description: Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.
arm group label: Compensated cirrhosis
arm group type: Experimental
description: Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g)
intervention type: Other
intervention name: Collecting Clinical Data
description: Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
arm group label: Compensated cirrhosis
arm group label: Decompensated cirrhosis
intervention type: Other
intervention name: Collecting laboratory data
description: Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
arm group label: Compensated cirrhosis
arm group label: Decompensated cirrhosis
criteria: 
gender: All
minimum age: 4 Months
maximum age: 50 Years
healthy volunteers: No
last name: Xavier Stephenne, MD, PhD
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Esophageal and Gastric Varices
sharing ipd: Undecided
ipd description: There is no plan at this time