xml: <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/NCT06037707</url>
    </required_header>
    <id_info>
      <org_study_id>DerinceTRH-07</org_study_id>
      <nct_id>NCT06037707</nct_id>
    </id_info>
    <brief_title>Thromboembolic Complications in COVID-19 Patients in Intensive Care Unit</brief_title>
    <acronym>COVID-19TC</acronym>
    <official_title>Incidence of Thromboembolism in COVID-19 Infection in the ICU: a Retrospective Cohort Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ayse Zeynep Turan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Derince Training and Research Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study aims to determine frequency of thromboembolic complications and the&#xD;
        underlying causes of this complication of the patients who admitted to the intensive care&#xD;
        unit diagnosed with COVID-19.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients diagnosed with COVID-19 infection and admitted to the ICU were recruited.&#xD;
        Demographic information, comorbidities, length of ICU stay, some laboratory&#xD;
        data,thromboembolic complications of the patients were recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease</measure>
      <time_frame>During the entire intensive care stay up to 1 day</time_frame>
      <description>Both arterial and venous thromboembolic events were detected</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of thromboembolic complications of COVID-19 disease in critically ill patients</measure>
      <time_frame>During the entire intensive care stay up to 1 day</time_frame>
      <description>Both arterial and venous thromboembolic events were detected</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of thromboembolic complications according to anticoagulant therapy</measure>
      <time_frame>During the entire intensive care stay up to 1 day</time_frame>
      <description>Antithrombotic therapy of each patient was recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>What is the rate of thromboembolism according to the comorbidities</measure>
      <time_frame>During the entire intensive care stay up to 1 day</time_frame>
      <description>Comorbidities of each patient were recorded from the patients records.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">484</enrollment>
    <condition>COVID-19-Associated Thromboembolism</condition>
    <arm_group>
      <arm_group_label>Ancestral variant</arm_group_label>
      <description>Ancestral variant is the first subtype of SARS CoV-2 virus which is the agent of first COVID-19 infection in Wuhan. Thromboembolic complications of this group were detected among patients which were infected with ancestral variant of COVID-19</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delta Variant</arm_group_label>
      <description>Delta variant is the subtype of SARS CoV-2 virus which is first COVID-19 subtype identified in India. Thromboembolic complications of this group were detected among patients which were infected with delta variant of COVID-19</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alpha variant</arm_group_label>
      <description>Alpha variant is the subtype of SARS CoV-2 virus which is first identified COVID-19 subtype in United Kingdom. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Other variants</arm_group_label>
      <description>Other variants is the subtype of SARS CoV-2 virus which were identified in Brazil, South Africa..etc. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Study Population of the present study is all of the patients diagnosed with COVID-19 and&#xD;
          admitted to the intensive care units at Derince Training and Research Hospital at the time&#xD;
          of between 1-March-2020 and 31-December-2021in&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who were infected with COVID-19 and admitted to the intensive care unit&#xD;
               between the time of March 2020-December 2021&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  who is under 18 years old.&#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>Berna Karakoyun Lacin, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Health and Science University Hamidiye Institute of Health Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Derince Research and Training Hospital</name>
        <address>
          <city>Kocaeli</city>
          <state>Derince</state>
          <zip>41900</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Derince Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Ayse Zeynep Turan</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>thromboembolism</keyword>
    <keyword>Variants of COVID-19</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Thromboembolism</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037707
  org study id: DerinceTRH-07
  nct id: NCT06037707
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The present study aims to determine frequency of thromboembolic complications and the
        underlying causes of this complication of the patients who admitted to the intensive care
        unit diagnosed with COVID-19.
  Patients diagnosed with COVID-19 infection and admitted to the ICU were recruited.
        Demographic information, comorbidities, length of ICU stay, some laboratory
        data,thromboembolic complications of the patients were recorded.
  observational model: Cohort
  time perspective: Retrospective
  measure: Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease
  time frame: During the entire intensive care stay up to 1 day
  description: Both arterial and venous thromboembolic events were detected
  measure: Rate of thromboembolic complications of COVID-19 disease in critically ill patients
  time frame: During the entire intensive care stay up to 1 day
  description: Both arterial and venous thromboembolic events were detected
  measure: Rate of thromboembolic complications according to anticoagulant therapy
  time frame: During the entire intensive care stay up to 1 day
  description: Antithrombotic therapy of each patient was recorded
  measure: What is the rate of thromboembolism according to the comorbidities
  time frame: During the entire intensive care stay up to 1 day
  description: Comorbidities of each patient were recorded from the patients records.
  arm group label: Ancestral variant
  description: Ancestral variant is the first subtype of SARS CoV-2 virus which is the agent of first COVID-19 infection in Wuhan. Thromboembolic complications of this group were detected among patients which were infected with ancestral variant of COVID-19
  arm group label: Delta Variant
  description: Delta variant is the subtype of SARS CoV-2 virus which is first COVID-19 subtype identified in India. Thromboembolic complications of this group were detected among patients which were infected with delta variant of COVID-19
  arm group label: Alpha variant
  description: Alpha variant is the subtype of SARS CoV-2 virus which is first identified COVID-19 subtype in United Kingdom. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19
  arm group label: Other variants
  description: Other variants is the subtype of SARS CoV-2 virus which were identified in Brazil, South Africa..etc. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Berna Karakoyun Lacin, Prof.
  role: Principal Investigator
  affiliation: Health and Science University Hamidiye Institute of Health Sciences
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Derince Training and Research Hospital
  investigator full name: Ayse Zeynep Turan
  investigator title: Principle Investigator
  mesh term: COVID-19
  mesh term: Thromboembolism