<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/NCT02969746</url>
  </required_header>
  <id_info>
    <org_study_id>CACAOD</org_study_id>
    <nct_id>NCT02969746</nct_id>
  </id_info>
  <brief_title>Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants</brief_title>
  <acronym>CACAOD</acronym>
  <official_title>Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicentric, randomized, open labeled superiority trial&#xD;
&#xD;
      This study aims to evaluate the efficacy of oral activated charcoal for improving elimination&#xD;
      of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive&#xD;
      procedure delayed to this anticoagulant treatment.&#xD;
&#xD;
      The primary outcome is the anticoagulant's half life. Plasma concentration will be measured&#xD;
      by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).&#xD;
&#xD;
      A total of 140 patients will randomly be assigned to the charcoal or control group,&#xD;
      stratified according to their anticoagulant drug.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Oral Anticoagulant half life</measure>
    <time_frame>0 to 8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to obtain a plasmatic concentration lower than 50ng/mL</measure>
    <time_frame>0 to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.</measure>
    <time_frame>until Day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events.</measure>
    <time_frame>day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Anticoagulants; Circulating, Hemorrhagic Disorder</condition>
  <arm_group>
    <arm_group_label>Charcoal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a single dose (20 gram) of oral activated charcoal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Activated Charcoal</intervention_name>
    <description>Patients will take oral activated charcoal after randomization in the intervention arm.&#xD;
A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4)</description>
    <arm_group_label>Charcoal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under direct oral anticoagulant treatment (Apixaban, Rivaroxaban or&#xD;
             Dabigatran)&#xD;
&#xD;
          -  Age ≥18 years;&#xD;
&#xD;
          -  Clinical condition needing a surgery or invasive procedure ( lumbar puncture,&#xD;
             biopsy...), needing anticoagulant treatment interruption and intervention to be&#xD;
             postponed&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urgent immediate surgery without any possibility to wait for 24 hours&#xD;
&#xD;
          -  contraindication for receiving oral treatment&#xD;
&#xD;
          -  Active uncontrolled bleeding or bleeding in critical organ&#xD;
&#xD;
          -  Hemodynamic instability, shock&#xD;
&#xD;
          -  Known anticoagulant concentration &lt; 50ng/mL&#xD;
&#xD;
          -  drug intoxication&#xD;
&#xD;
          -  Fructose intolerance, glucose and galactose malabsorption syndrome, sucrase-isomaltase&#xD;
             deficit&#xD;
&#xD;
          -  Treated epileptic disease&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  No insurance cover&#xD;
&#xD;
          -  Patient unable to give his consent&#xD;
&#xD;
          -  Participation to another therapeutic trial&#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>Thomas Moumneh, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sponsor GmbH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Moumneh, Dr</last_name>
    <phone>+33241356650</phone>
    <email>thomas.moumneh@chu-angers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Guillaume Bouhours, Dr</last_name>
      <phone>33241353634</phone>
    </contact>
    <contact_backup>
      <email>gubouhours@chu-angers.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Guillaume BOUHOURS, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-ferrand</name>
      <address>
        <city>Cleron</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Jeannot Schmidt, Dr</last_name>
    </contact>
    <contact_backup>
      <phone>33 4 73 75 15 64</phone>
      <email>jschmidt@clermontferrand.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Jeannot Schmidt, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Le MANS</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Thibault Schotté, Dr</last_name>
    </contact>
    <contact_backup>
      <phone>+33 2 43 43 29 19</phone>
      <email>tschotte@ch-lemans.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Thibault Schotté, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Nicolas Marjanovic, Pr</last_name>
      <email>n.marjanovic@chu-poitiers.fr</email>
    </contact>
    <investigator>
      <last_name>Nicolas Marjanovic, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de St Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Alain Viallon, Dr</last_name>
      <phone>04 77 82 94 06</phone>
      <email>alain.viallon@chu-st-etienne.fr</email>
    </contact>
    <investigator>
      <last_name>Alain Viallon, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>activated charcoal, direct oral anticoagulant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhagic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Charcoal</mesh_term>
  </intervention_browse>
  <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/NCT02969746
org study id: CACAOD
nct id: NCT02969746
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective, multicentric, randomized, open labeled superiority trial

      This study aims to evaluate the efficacy of oral activated charcoal for improving elimination
      of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive
      procedure delayed to this anticoagulant treatment.

      The primary outcome is the anticoagulant's half life. Plasma concentration will be measured
      by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

      A total of 140 patients will randomly be assigned to the charcoal or control group,
      stratified according to their anticoagulant drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Direct Oral Anticoagulant half life
time frame: 0 to 8 hours
measure: Time to obtain a plasmatic concentration lower than 50ng/mL
time frame: 0 to 8 hours
measure: Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.
time frame: until Day 7
measure: Number of patients with adverse events.
time frame: day 7
arm group label: Charcoal
arm group type: Experimental
description: Patients will receive a single dose (20 gram) of oral activated charcoal
arm group label: control
arm group type: No Intervention
description: Standard practice
intervention type: Drug
intervention name: Activated Charcoal
description: Patients will take oral activated charcoal after randomization in the intervention arm.
A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4)
arm group label: Charcoal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Moumneh, Dr
role: Principal Investigator
affiliation: Sponsor GmbH
last name: Thomas Moumneh, Dr
phone: +33241356650
email: thomas.moumneh@chu-angers.fr
facility: 
contact: 
contact backup: 
investigator: 
facility: 
facility: 
contact: 
contact backup: 
investigator: 
facility: 
contact: 
contact backup: 
investigator: 
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Hemorrhagic Disorders
mesh term: Charcoal
sharing ipd: No