<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/NCT02213978</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-VTE-2014</org_study_id>
    <nct_id>NCT02213978</nct_id>
  </id_info>
  <brief_title>A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients</brief_title>
  <acronym>VTEH</acronym>
  <official_title>A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the effect of the prophylaxis of venous&#xD;
      thromboembolism in the critical ill patients, and at the same time, to find out the risk of&#xD;
      venous thromboembolism and hemorrhage events occurred under the prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients</measure>
    <time_frame>2 weeks</time_frame>
    <description>at the same time, to analyze the risk factor of the occurrence of venous thromboembolism despite of thromboprophylaxis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence of bleeding events under thromboprophylaxis in critical ill patients</measure>
    <time_frame>2 weeks</time_frame>
    <description>at the same time, to analyze the risk factors of bleeding in critical ill patients who receive thromboprophylaxis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the incidence of venous thromboembolism under the mechanical thromboprophylaxis in the critical ill patients who with the contraindications to anticoagulation</measure>
    <time_frame>2 weeks</time_frame>
    <description>At the same time,to analyze the aspects below:&#xD;
Evaluation the tolerance to mechanical thromboprophylaxis of these patients&#xD;
Comparison of the effectiveness between intermittent pneumatic compression and graduated compression stockings in mechanical thromboprophylaxis</description>
  </other_outcome>
  <enrollment type="Actual">1114</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Hemorrhage</condition>
  <eligibility>
    <study_pop>
      <textblock>
        the critical ill patients in ICUs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all the patients in ICUs estimated time in ICU mare than 48h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  estimated time in ICU less than 48h refused to attend&#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>Xiao Tang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao-Yang Hospital,China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of respiratory and critical care medicine,Beijing Chao-yang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>January 10, 2022</last_update_submitted>
  <last_update_submitted_qc>January 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Xiao Tang</investigator_full_name>
    <investigator_title>doctor of the department of respiratory and critical care medicine of Beijing Chao Yang Hospital</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>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT02213978
org study id: ICU-VTE-2014
nct id: NCT02213978
lead sponsor: 
has dmc: Yes
The purpose of this study is to analyze the effect of the prophylaxis of venous
      thromboembolism in the critical ill patients, and at the same time, to find out the risk of
      venous thromboembolism and hemorrhage events occurred under the prophylaxis.
observational model: Cohort
time perspective: Prospective
measure: the incidence of venous thromboembolism under the thromboprophylaxis in critical ill patients
time frame: 2 weeks
description: at the same time, to analyze the risk factor of the occurrence of venous thromboembolism despite of thromboprophylaxis
measure: the incidence of bleeding events under thromboprophylaxis in critical ill patients
time frame: 2 weeks
description: at the same time, to analyze the risk factors of bleeding in critical ill patients who receive thromboprophylaxis
measure: the incidence of venous thromboembolism under the mechanical thromboprophylaxis in the critical ill patients who with the contraindications to anticoagulation
time frame: 2 weeks
description: At the same time,to analyze the aspects below:
Evaluation the tolerance to mechanical thromboprophylaxis of these patients
Comparison of the effectiveness between intermittent pneumatic compression and graduated compression stockings in mechanical thromboprophylaxis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiao Tang, MD
role: Principal Investigator
affiliation: Beijing Chao-Yang Hospital,China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Xiao Tang
investigator title: doctor of the department of respiratory and critical care medicine of Beijing Chao Yang Hospital
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Hemorrhage