<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/NCT04462614</url>
  </required_header>
  <id_info>
    <org_study_id>PO20091</org_study_id>
    <nct_id>NCT04462614</nct_id>
  </id_info>
  <brief_title>Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA</brief_title>
  <acronym>REMARK</acronym>
  <official_title>Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</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>
      Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions,&#xD;
      with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA,&#xD;
      without addition of heparin perdialytic.&#xD;
&#xD;
      Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of&#xD;
      bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™&#xD;
      membrane and treated by long-term anticoagulation with VKA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim will be to study possibility of hemodialysis sessions success, without perdialytic&#xD;
      anticoagulation but with adequate dialysis parameters (defined by the patient's Kt / V&#xD;
      machine), in patients treated by long-term anticoagulation with VKA and dialysed with the&#xD;
      HeprAN ™ membrane.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters</measure>
    <time_frame>3 weeks</time_frame>
    <description>Failure is defined by&#xD;
early interruption of the dialysis session (&lt;95% of the prescribed time) for :&#xD;
extracorporeal circuit coagulation&#xD;
recurrent venous pressure alarm causing blood pump shutdown or&#xD;
Lower quality of dialysis compared to the quality before stopping perdialytic anticoagulation (defined as Kt/V less than - 2SD for 3 consecutive sessions)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">49</enrollment>
  <condition>Chronic Hemolysis</condition>
  <condition>VKA</condition>
  <condition>Anticoagulants / Administration &amp; Dosage</condition>
  <condition>Coated Materials</condition>
  <condition>Biocompatible</condition>
  <condition>Heparin / Administration &amp; Dosage</condition>
  <condition>Membranes Artificial</condition>
  <condition>Prospective Studies</condition>
  <condition>Renal Dialysis / Methods</condition>
  <condition>Renal Insufficiency / Therapy</condition>
  <arm_group>
    <arm_group_label>single-arm study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic hemodialysis patients for at least 3 months at Reims University Hospital, treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decrease per-dialytic heparin therapy</intervention_name>
    <description>Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.</description>
    <arm_group_label>single-arm study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria :&#xD;
&#xD;
          -  18 years old and older&#xD;
&#xD;
          -  chronic hemodialysis for at least 3 months&#xD;
&#xD;
          -  treated by long-term anticoagulation with VKA&#xD;
&#xD;
          -  hemodialysis with the HeprAN® membrane&#xD;
&#xD;
          -  per dialytic heparin therapy (UFH or LMWH)&#xD;
&#xD;
          -  dialyzed at Reims University Hospital&#xD;
&#xD;
          -  agreeing to participate in the study&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  chronic hemodialysis without per dialytic heparin&#xD;
&#xD;
          -  Patient dialized with single lumen catheter for vascular access&#xD;
&#xD;
          -  less than 18 years old&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  protected by law&#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_contact>
    <last_name>Antoine BRACONNIER</last_name>
    <phone>03 26 78 41 40</phone>
    <phone_ext>0033</phone_ext>
    <email>abraconnier@chu-reims.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Damien JOLLY</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Antoine BRACONNIER</last_name>
      <phone>03 26 78 41 40</phone>
      <phone_ext>0033</phone_ext>
      <email>abraconnier@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</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>Renal Insufficiency</mesh_term>
    <mesh_term>Hemolysis</mesh_term>
  </condition_browse>
  <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/NCT04462614
org study id: PO20091
nct id: NCT04462614
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions,
      with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA,
      without addition of heparin perdialytic.

      Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of
      bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™
      membrane and treated by long-term anticoagulation with VKA
The aim will be to study possibility of hemodialysis sessions success, without perdialytic
      anticoagulation but with adequate dialysis parameters (defined by the patient's Kt / V
      machine), in patients treated by long-term anticoagulation with VKA and dialysed with the
      HeprAN ™ membrane.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters
time frame: 3 weeks
description: Failure is defined by
early interruption of the dialysis session (<95% of the prescribed time) for :
extracorporeal circuit coagulation
recurrent venous pressure alarm causing blood pump shutdown or
Lower quality of dialysis compared to the quality before stopping perdialytic anticoagulation (defined as Kt/V less than - 2SD for 3 consecutive sessions)
arm group label: single-arm study
arm group type: Experimental
description: Chronic hemodialysis patients for at least 3 months at Reims University Hospital, treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane
intervention type: Drug
intervention name: Decrease per-dialytic heparin therapy
description: Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.
arm group label: single-arm study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine BRACONNIER
phone: 03 26 78 41 40
phone ext: 0033
email: abraconnier@chu-reims.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Hemolysis
mesh term: Heparin