<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/NCT03752437</url>
  </required_header>
  <id_info>
    <org_study_id>MDKR</org_study_id>
    <nct_id>NCT03752437</nct_id>
  </id_info>
  <brief_title>Comparison of Two Dosages of Heparin Before Extracorporeal Circulation</brief_title>
  <official_title>Comparison of Two Dosages of Heparin Before Extracorporeal Circulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astes</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 this study the investigators will study two dosages of heparin before extracorporeal&#xD;
      circulation in open chest cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators will study two dosages of heparin before extracorporeal&#xD;
      circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of&#xD;
      REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Randomisation by computer, different sheet for encoding data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ACT performance</measure>
    <time_frame>1 minute</time_frame>
    <description>Measure of ACT to be &gt; 400 seconds to allow extracorporeal circulation, but also &lt; 700 seconds to avoid excessive bleeding.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Extracorporeal Circulation; Complications</condition>
  <arm_group>
    <arm_group_label>Real Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ideal Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ACT (Activated Clotting Time)</intervention_name>
    <description>Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.</description>
    <arm_group_label>Ideal Weight</arm_group_label>
    <arm_group_label>Real Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <description>300 IU of heparin</description>
    <arm_group_label>Ideal Weight</arm_group_label>
    <arm_group_label>Real Weight</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted for cardiac open chest surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal&#xD;
&#xD;
          -  Antithrombin III factor &lt; 75%&#xD;
&#xD;
          -  Patient under treatment by heparin IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Deflandre, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Astes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Saint-Luc of Bouge</name>
      <address>
        <city>Namur</city>
        <zip>5004</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Astes</investigator_affiliation>
    <investigator_full_name>Eric DEFLANDRE, MD, PhD, FCCP, FAHA</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03752437
org study id: MDKR
nct id: NCT03752437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the investigators will study two dosages of heparin before extracorporeal
      circulation in open chest cardiac surgery.
In this study the investigators will study two dosages of heparin before extracorporeal
      circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of
      REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
masking description: Randomisation by computer, different sheet for encoding data.
measure: ACT performance
time frame: 1 minute
description: Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding.
arm group label: Real Weight
arm group type: Experimental
description: Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.
arm group label: Ideal Weight
arm group type: Experimental
description: Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.
intervention type: Diagnostic Test
intervention name: ACT (Activated Clotting Time)
description: Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.
arm group label: Ideal Weight
arm group label: Real Weight
intervention type: Drug
intervention name: Heparin
description: 300 IU of heparin
arm group label: Ideal Weight
arm group label: Real Weight
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Deflandre, MD, PhD
role: Principal Investigator
affiliation: Astes
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Astes
investigator full name: Eric DEFLANDRE, MD, PhD, FCCP, FAHA
investigator title: Head of Department
mesh term: Heparin