<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/NCT03802929</url>
  </required_header>
  <id_info>
    <org_study_id>DOMESTIC</org_study_id>
    <nct_id>NCT03802929</nct_id>
  </id_info>
  <brief_title>Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism</brief_title>
  <official_title>The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ya-Wei Xu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai 10th People's 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>
      The objective of this proposal is to develop and validate diagnostic and prognostic&#xD;
      (including short-term and long-term prognoses) prediction models for patients with venous&#xD;
      thromboembolism (VTE) in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and&#xD;
      pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately&#xD;
      diagnosed and effectively managed. Although a number of clinical decision rules in the domain&#xD;
      of VTE have been presented in the literature, such as the well-known prediction models&#xD;
      developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in&#xD;
      patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for&#xD;
      short-term mortality risk in PE patients, and various other diagnostic models for both DVT&#xD;
      and PE. They are few designed for Chinese patients. The primary objective of this proposal is&#xD;
      to develop and validate diagnostic and prognostic (including short-term and long-term&#xD;
      prognoses) prediction models for patients with VTE in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Death from all causes</measure>
    <time_frame>5-year</time_frame>
    <description>Death from all causes during follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from all causes</measure>
    <time_frame>30-day</time_frame>
    <description>Death from all causes during hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Recurrent VTE</measure>
    <time_frame>5-year</time_frame>
    <description>Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)</measure>
    <time_frame>5-year</time_frame>
    <description>CTEPH can be diagnosed by an echocardiogram or a CTPA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants with Cardiogenic Shock</measure>
    <time_frame>30-day</time_frame>
    <description>Cardiogenic shock defined as hemodynamic instability(systolic blood pressure&lt;90 mm Hg, or use of inotropic support）</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Venous Thromboembolism (VTE)</condition>
  <arm_group>
    <arm_group_label>Derivation Cohort</arm_group_label>
    <description>Derivation Cohort of Diagnostic Prediction Model:&#xD;
Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort.&#xD;
Derivation Cohort of Prognostic Prediction Model:&#xD;
Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation Cohort</arm_group_label>
    <description>Validation Cohort of Diagnostic Prediction Model:&#xD;
The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort.&#xD;
Validation Cohort of Prognostic Prediction Model:&#xD;
New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood collected at various time points according to the study cohort&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Development and validation of diagnostic prediction model:&#xD;
&#xD;
        Participants will undergo recruitment from the emergency department of five general urban&#xD;
        hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of&#xD;
        Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan&#xD;
        Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1,&#xD;
        2019.&#xD;
&#xD;
        Development and validation of prognostic prediction model:&#xD;
&#xD;
        The investigators will identify patients with VTE from 5 thrombosis centers in China,&#xD;
        including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical&#xD;
        University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui&#xD;
        Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and&#xD;
        December 2018 using the Hospital Information Manage System(HIMS) database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt; 18 years old&#xD;
&#xD;
          2. First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed&#xD;
             tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as&#xD;
             high probability by the radiologist, and/or (+) bilateral lower limb venous&#xD;
             compression ultrasonography (CCUS))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with prior VTE&#xD;
&#xD;
          2. Cannot provide written informed consent&#xD;
&#xD;
          3. Unable to read questionnaire in Chinese or English&#xD;
&#xD;
          4. a record of pregnancy in the preceding 12 months&#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>Dachun Xu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dachun Xu, Ph.D</last_name>
    <phone>0086-18917684045</phone>
    <email>xdc77@tongji.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fan Wang, MD</last_name>
    <phone>0086-15216717487</phone>
    <email>15216717487@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital, Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dachun Xu, MD,PhD</last_name>
      <phone>+86 18917684045</phone>
      <email>xdc77@tongji.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yawei Xu, MD,PhD</last_name>
      <phone>+86 13916698181</phone>
      <email>xuyawei@tongji.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Ya-Wei Xu</investigator_full_name>
    <investigator_title>Head of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03802929
org study id: DOMESTIC
nct id: NCT03802929
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this proposal is to develop and validate diagnostic and prognostic
      (including short-term and long-term prognoses) prediction models for patients with venous
      thromboembolism (VTE) in China.
Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and
      pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately
      diagnosed and effectively managed. Although a number of clinical decision rules in the domain
      of VTE have been presented in the literature, such as the well-known prediction models
      developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in
      patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for
      short-term mortality risk in PE patients, and various other diagnostic models for both DVT
      and PE. They are few designed for Chinese patients. The primary objective of this proposal is
      to develop and validate diagnostic and prognostic (including short-term and long-term
      prognoses) prediction models for patients with VTE in China.
observational model: Cohort
time perspective: Prospective
measure: Death from all causes
time frame: 5-year
description: Death from all causes during follow-up
measure: Death from all causes
time frame: 30-day
description: Death from all causes during hospitalization
measure: Number of Participants with Recurrent VTE
time frame: 5-year
description: Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.
measure: Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
time frame: 5-year
description: CTEPH can be diagnosed by an echocardiogram or a CTPA.
measure: Number of Participants with Cardiogenic Shock
time frame: 30-day
description: Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support）
arm group label: Derivation Cohort
description: Derivation Cohort of Diagnostic Prediction Model:
Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort.
Derivation Cohort of Prognostic Prediction Model:
Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018.
arm group label: Validation Cohort
description: Validation Cohort of Diagnostic Prediction Model:
The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort.
Validation Cohort of Prognostic Prediction Model:
New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019.
Peripheral blood collected at various time points according to the study cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dachun Xu, Ph.D
role: Principal Investigator
affiliation: Shanghai 10th People's Hospital
last name: Dachun Xu, Ph.D
phone: 0086-18917684045
email: xdc77@tongji.edu.cn
last name: Fan Wang, MD
phone: 0086-15216717487
email: 15216717487@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Ya-Wei Xu
investigator title: Head of Cardiology
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
sharing ipd: Undecided