<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/NCT04412304</url>
  </required_header>
  <id_info>
    <org_study_id>Anticoagulant therapy Covid-19</org_study_id>
    <nct_id>NCT04412304</nct_id>
  </id_info>
  <brief_title>Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients</brief_title>
  <official_title>Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</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 aims of the study are to to associate anticoagulation (AC) regime with outcome in&#xD;
      critically ill patients with Covid-19. This will be done by describe baseline characteristics&#xD;
      and comorbidities before hospital admission, level of organ support and dose of AC treatment&#xD;
      and associate this with 28 days survival, survival outside ICU, thromboembolic event and&#xD;
      bleeding complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>28-days ICU mortality</measure>
    <time_frame>28 days from ICU-admission</time_frame>
    <description>28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of thromboembolic events</measure>
    <time_frame>28 days from ICU-admission</time_frame>
    <description>Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bleeding events</measure>
    <time_frame>28 days from ICU-admission</time_frame>
    <description>The event of bleeding will be defined by WHO modified bleeding scale as 1-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU-free days alive from ICU-admission.</measure>
    <time_frame>28 days from ICU-admission</time_frame>
    <description>ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>D-dimer levels in the three groups groups</measure>
    <time_frame>28 days from ICU-admission</time_frame>
    <description>D-dimer every day it is measured during first 28 days from ICU-admission.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">166</enrollment>
  <condition>Covid-19</condition>
  <condition>Thromboembolic Events</condition>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>thrombose prophylaxis</arm_group_label>
    <description>The dose used to prevent thromboembolic complication in critically ill</description>
  </arm_group>
  <arm_group>
    <arm_group_label>double thrombose prophylaxis</arm_group_label>
    <description>Double the dose used to prevent thromboembolic complication in critically ill</description>
  </arm_group>
  <arm_group>
    <arm_group_label>full dose anticoagulant</arm_group_label>
    <description>Dose used to treat thromboembolic event</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dose of Tinzaparin or Dalteparin</intervention_name>
    <description>The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.</description>
    <arm_group_label>double thrombose prophylaxis</arm_group_label>
    <arm_group_label>full dose anticoagulant</arm_group_label>
    <arm_group_label>thrombose prophylaxis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General&#xD;
        Hospital from March 6th 2020 to April 30 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laboratory confirmed positive test for SARS-CoV-2&#xD;
&#xD;
          -  admitted to ICU because of critical illness due to covid-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with treatment for thromboembolic complications at arrival to the ICU&#xD;
&#xD;
          -  short ICU length of stay defined as discharged the same or the following day as ICU&#xD;
             admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Cronhjort, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Department of Clinical Science and Education</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South General Hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms Län</state>
        <zip>11880</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Christer Svensen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dalteparin</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
  </intervention_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/NCT04412304
org study id: Anticoagulant therapy Covid-19
nct id: NCT04412304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims of the study are to to associate anticoagulation (AC) regime with outcome in
      critically ill patients with Covid-19. This will be done by describe baseline characteristics
      and comorbidities before hospital admission, level of organ support and dose of AC treatment
      and associate this with 28 days survival, survival outside ICU, thromboembolic event and
      bleeding complications.
observational model: Cohort
time perspective: Retrospective
measure: 28-days ICU mortality
time frame: 28 days from ICU-admission
description: 28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.
measure: Incidence of thromboembolic events
time frame: 28 days from ICU-admission
description: Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.
measure: Incidence of bleeding events
time frame: 28 days from ICU-admission
description: The event of bleeding will be defined by WHO modified bleeding scale as 1-4.
measure: ICU-free days alive from ICU-admission.
time frame: 28 days from ICU-admission
description: ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.
measure: D-dimer levels in the three groups groups
time frame: 28 days from ICU-admission
description: D-dimer every day it is measured during first 28 days from ICU-admission.
arm group label: thrombose prophylaxis
description: The dose used to prevent thromboembolic complication in critically ill
arm group label: double thrombose prophylaxis
description: Double the dose used to prevent thromboembolic complication in critically ill
arm group label: full dose anticoagulant
description: Dose used to treat thromboembolic event
intervention type: Drug
intervention name: Dose of Tinzaparin or Dalteparin
description: The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.
arm group label: double thrombose prophylaxis
arm group label: full dose anticoagulant
arm group label: thrombose prophylaxis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maria Cronhjort, PhD
role: Principal Investigator
affiliation: Karolinska Institutet, Department of Clinical Science and Education
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Christer Svensen
investigator title: Professor
mesh term: COVID-19
mesh term: Thromboembolism
mesh term: Dalteparin
mesh term: Tinzaparin
mesh term: Heparin, Low-Molecular-Weight