<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/NCT04507282</url>
  </required_header>
  <id_info>
    <org_study_id>Bursa Postgraduate Hospital</org_study_id>
    <nct_id>NCT04507282</nct_id>
  </id_info>
  <brief_title>Eosinophil and Anticoagulation in COVID-19 Patients</brief_title>
  <official_title>Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bursa Postgraduate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bursa Postgraduate Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite prophylactic anticoagulant treatments, thrombotic complications may develop in&#xD;
      patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor&#xD;
      Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in&#xD;
      COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>subprophylactic anticogulation level</measure>
    <time_frame>14 days</time_frame>
    <description>&lt;0.2IU/ml</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID 19 positive patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LMWH</intervention_name>
    <description>COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level</description>
    <arm_group_label>COVID 19 positive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COVID 19 positive patients treated with LMWH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years, who were diagnosed with COVID-19 and were administered&#xD;
             LMWH,&#xD;
&#xD;
          -  agreed to participate in the study were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous coagulopathy,&#xD;
&#xD;
          -  continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve&#xD;
             disease),&#xD;
&#xD;
          -  glomerular filtration rate (GFR) &lt;30 mL/min or undergoing dialysis, or with known&#xD;
             liver dysfunction were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Bursa Yüksek İhtisas Hastanesi</name>
      <address>
        <city>Yıldırım</city>
        <zip>16310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 15, 2020</last_update_submitted>
  <last_update_submitted_qc>August 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bursa Postgraduate Hospital</investigator_affiliation>
    <investigator_full_name>Hasan ARI</investigator_full_name>
    <investigator_title>Medical Doctor of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_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/NCT04507282
org study id: Bursa Postgraduate Hospital
nct id: NCT04507282
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Despite prophylactic anticoagulant treatments, thrombotic complications may develop in
      patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor
      Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in
      COVID-19 patients.
observational model: Cohort
time perspective: Prospective
measure: subprophylactic anticogulation level
time frame: 14 days
description: <0.2IU/ml
arm group label: COVID 19 positive patients
intervention type: Drug
intervention name: LMWH
description: COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level
arm group label: COVID 19 positive patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bursa Postgraduate Hospital
investigator full name: Hasan ARI
investigator title: Medical Doctor of Cardiology
mesh term: COVID-19
sharing ipd: No