<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/NCT03269019</url>
  </required_header>
  <id_info>
    <org_study_id>2017CX05</org_study_id>
    <nct_id>NCT03269019</nct_id>
  </id_info>
  <brief_title>Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia</brief_title>
  <official_title>Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia</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>
      Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications&#xD;
      after the application of heparin. If HIT without treatment, death rate is as high as 30% to&#xD;
      50%. Early diagnosis of HIT and prevention of thrombosis is very important.&#xD;
&#xD;
      This study is planned to assess the use of thrombotic biomarkers in patients with HIT,&#xD;
      including thrombin-antithrombin complex, d-dimer, fibrin degradation products and&#xD;
      Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to&#xD;
      assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and&#xD;
      clinical outcomes, including new thrombus and death, were recorded during follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thrombotic event</measure>
    <time_frame>30 days</time_frame>
    <description>New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Deaths</measure>
    <time_frame>30 days</time_frame>
    <description>All-cause deaths</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Heparin-Induced Thrombocytopenia</condition>
  <condition>Thrombosis</condition>
  <condition>Biomarkers</condition>
  <arm_group>
    <arm_group_label>HIT-group</arm_group_label>
    <description>The patients with heparin-induced thrombocytopenia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HITTs-group</arm_group_label>
    <description>The patients with heparin-induced thrombocytopenia with thrombosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HIT with thrombosis</intervention_name>
    <description>Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.</description>
    <arm_group_label>HIT-group</arm_group_label>
    <arm_group_label>HITTs-group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are those who receiving cardiac surgery, including valve replacementheart,Coronary&#xD;
        Artery Bypass Grafting,aorta replacement etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients undergoing cardiac surgery.&#xD;
&#xD;
          -  Receiving unfractionated heparin anticoagulation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of heparin-induced thrombocytopenia&#xD;
&#xD;
          -  pregnant woman&#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>Zhenlu Zhang, MD,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Asia Heart Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qingkun Fan, MD</last_name>
    <phone>+86 027 65796747</phone>
    <email>fqk@wahh.com.cn</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heparin-induced thrombocytopenia</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>thrombin-antithrombin</keyword>
  <keyword>d-dimer</keyword>
  <keyword>Thrombelastograghy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are going to make individual participant data (IPD) available to other researchers after our paper published.</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/NCT03269019
org study id: 2017CX05
nct id: NCT03269019
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications
      after the application of heparin. If HIT without treatment, death rate is as high as 30% to
      50%. Early diagnosis of HIT and prevention of thrombosis is very important.

      This study is planned to assess the use of thrombotic biomarkers in patients with HIT,
      including thrombin-antithrombin complex, d-dimer, fibrin degradation products and
      Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to
      assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and
      clinical outcomes, including new thrombus and death, were recorded during follow-up.
observational model: Cohort
time perspective: Prospective
measure: Thrombotic event
time frame: 30 days
description: New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
measure: Deaths
time frame: 30 days
description: All-cause deaths
arm group label: HIT-group
description: The patients with heparin-induced thrombocytopenia.
arm group label: HITTs-group
description: The patients with heparin-induced thrombocytopenia with thrombosis.
arm group label: Control group
description: The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.
intervention type: Diagnostic Test
intervention name: HIT with thrombosis
description: Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.
arm group label: HIT-group
arm group label: HITTs-group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhenlu Zhang, MD,Ph.D
role: Study Director
affiliation: Wuhan Asia Heart Hospital
last name: Qingkun Fan, MD
phone: +86 027 65796747
email: fqk@wahh.com.cn
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Thrombocytopenia
sharing ipd: Undecided
ipd description: We are going to make individual participant data (IPD) available to other researchers after our paper published.