<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/NCT03261284</url>
  </required_header>
  <id_info>
    <org_study_id>2017-P-032</org_study_id>
    <nct_id>NCT03261284</nct_id>
  </id_info>
  <brief_title>D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD</brief_title>
  <acronym>DIAMOND</acronym>
  <official_title>D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Asia Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Asia Heart Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a prospective, cohort study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort.&#xD;
      Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is&#xD;
      monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue&#xD;
      to rise (&gt;1.5 times previous result ), increase the dose of heparin to reach the upper limit&#xD;
      of the treatment target; If the D-dimer levels is stable (&lt;1.5 times previous result ) or is&#xD;
      decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or&#xD;
      decreased (active bleeding). All patients were followed up The occurrence of endpoints during&#xD;
      in-hospital and 30 days after discharge, including bleeding events, thrombotic events and&#xD;
      all-cause deaths were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Sequential Assignment</intervention_model>
    <intervention_model_description>D-dimer is mornitored. If D-dimer levels continue to rise (&gt;1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (&lt;1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thrombotic events</measure>
    <time_frame>24 months</time_frame>
    <description>Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hemorrhagic events</measure>
    <time_frame>24 months</time_frame>
    <description>cerebral hemorrhage,Gastrointestinal bleeding etc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>all-cause deaths</measure>
    <time_frame>24 months</time_frame>
    <description>all-cause deaths</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Extracorporeal Membrane Oxygenation Complication</condition>
  <condition>Thrombosis</condition>
  <condition>Hemorrhage</condition>
  <condition>Heparin Overdose</condition>
  <arm_group>
    <arm_group_label>DIAMOND group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-dimer and anti-Xa are mornitored. If D-dimer levels continue to rise (&gt;1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (&lt;1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heparin dose adjusted according to anti-Xa activity or activated partial thromboplastin time (aPTT). The target range is aPTT 1.5 to 2.5 times the upper limit of normal or therapeutic anti-Xa levels (0.3 U/ml to 0.7 U/ml) for unfractionated heparin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>D-dimer-guided adjustment stratege</intervention_name>
    <description>D-dimer-guided adjustment stratege</description>
    <arm_group_label>DIAMOND group</arm_group_label>
    <other_name>Heparin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thepeautic-heparin therapy</intervention_name>
    <description>0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Patients&#xD;
&#xD;
          -  Receiving ECMO surpport for any reason&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The duration of ECMO surpport was less than 24 hours .&#xD;
&#xD;
          -  Those who had difficulty in compliance or were unavailable for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenlu ZHANG, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Asia Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhang litao</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Asia Heart Hospital</investigator_affiliation>
    <investigator_full_name>Litao Zhang</investigator_full_name>
    <investigator_title>Director of Thrombosis centre</investigator_title>
  </responsible_party>
  <keyword>D-dimer</keyword>
  <keyword>Extracorporeal Membrane Oxygenation</keyword>
  <keyword>heparin</keyword>
  <keyword>anticoagulant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</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/NCT03261284
org study id: 2017-P-032
nct id: NCT03261284
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This was a prospective, cohort study.
Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort.
      Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is
      monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue
      to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit
      of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is
      decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or
      decreased (active bleeding). All patients were followed up The occurrence of endpoints during
      in-hospital and 30 days after discharge, including bleeding events, thrombotic events and
      all-cause deaths were recorded.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: D-dimer is mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).
primary purpose: Treatment
masking: None (Open Label)
measure: Thrombotic events
time frame: 24 months
description: Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
measure: hemorrhagic events
time frame: 24 months
description: cerebral hemorrhage,Gastrointestinal bleeding etc.
measure: all-cause deaths
time frame: 24 months
description: all-cause deaths
arm group label: DIAMOND group
arm group type: Experimental
description: D-dimer and anti-Xa are mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).
arm group label: Control group
arm group type: Active Comparator
description: Heparin dose adjusted according to anti-Xa activity or activated partial thromboplastin time (aPTT). The target range is aPTT 1.5 to 2.5 times the upper limit of normal or therapeutic anti-Xa levels (0.3 U/ml to 0.7 U/ml) for unfractionated heparin.
intervention type: Diagnostic Test
intervention name: D-dimer-guided adjustment stratege
description: D-dimer-guided adjustment stratege
arm group label: DIAMOND group
other name: Heparin
intervention type: Diagnostic Test
intervention name: Thepeautic-heparin therapy
description: 0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhenlu ZHANG, MD,PhD
role: Study Director
affiliation: Wuhan Asia Heart Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan Asia Heart Hospital
investigator full name: Litao Zhang
investigator title: Director of Thrombosis centre
mesh term: Thrombosis
mesh term: Hemorrhage
mesh term: Heparin
mesh term: Calcium heparin
sharing ipd: No