<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/NCT04479280</url>
  </required_header>
  <id_info>
    <org_study_id>17300446</org_study_id>
    <nct_id>NCT04479280</nct_id>
  </id_info>
  <brief_title>Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.</brief_title>
  <official_title>Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome&#xD;
      coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China&#xD;
      and rapidly spread around the world .&#xD;
&#xD;
      Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and&#xD;
      is associated with increased mortality and admission to critical care. Most observed&#xD;
      coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is&#xD;
      characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive&#xD;
      hospitalization reported to have developed disseminated intravascular coagulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 16, 2020</completion_date>
  <primary_completion_date type="Actual">August 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clot rate formation</measure>
    <time_frame>30 minutes</time_frame>
    <description>measuring how rapid the sample will get clotted</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>Covid19 positive patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Covid19 negative patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA</intervention_name>
    <description>studying coagulation disorders in COVID19 critically ill patients</description>
    <arm_group_label>Covid19 negative patients</arm_group_label>
    <arm_group_label>Covid19 positive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who are suspected to be COVID 19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID 19 critically ill patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any critical illness not related to COVID 19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Azza Abdelaal</investigator_full_name>
    <investigator_title>lecturer of clinical pathology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT04479280
org study id: 17300446
nct id: NCT04479280
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China
      and rapidly spread around the world .

      Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and
      is associated with increased mortality and admission to critical care. Most observed
      coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is
      characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive
      hospitalization reported to have developed disseminated intravascular coagulation
observational model: Case-Control
time perspective: Prospective
measure: clot rate formation
time frame: 30 minutes
description: measuring how rapid the sample will get clotted
arm group label: Covid19 positive patients
arm group label: Covid19 negative patients
intervention type: Device
intervention name: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
description: studying coagulation disorders in COVID19 critically ill patients
arm group label: Covid19 negative patients
arm group label: Covid19 positive patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Azza Abdelaal
investigator title: lecturer of clinical pathology
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders