<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/NCT04479124</url>
  </required_header>
  <id_info>
    <org_study_id>KSSTHR-TPED</org_study_id>
    <nct_id>NCT04479124</nct_id>
  </id_info>
  <brief_title>The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul</brief_title>
  <official_title>The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. The aim of this multi-centered study is to guide for the&#xD;
      approach, organization, diagnosis and treatment of the patients admitted due to trauma to&#xD;
      emergency department during the pandemic period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. The investigators hypothesize that since the number of hospital&#xD;
      applications expected to be decreased due to trauma during the COVID-19 period, the level of&#xD;
      hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide&#xD;
      for the approach, organization, diagnosis and treatment of the patients admitted due to&#xD;
      trauma to emergency department during the pandemic period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>trauma admissions</measure>
    <time_frame>3 months</time_frame>
    <description>within the study period, trauma patients who admitted to any of the seven study centers will be recorded.</description>
  </primary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Trauma</condition>
  <condition>Covid19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 PCR</intervention_name>
    <description>Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who admitted to any of the emergency departments of seven study centers during&#xD;
        the pandemic will be evaluated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  accepted to participate with an informed consent&#xD;
&#xD;
          -  trauma patients who admitted to the study centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of informed consent&#xD;
&#xD;
          -  lack of data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Kucukcekmece</state>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 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>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ramazan Guven</investigator_full_name>
    <investigator_title>Proffessor</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>Emergencies</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04479124
org study id: KSSTHR-TPED
nct id: NCT04479124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. The aim of this multi-centered study is to guide for the
      approach, organization, diagnosis and treatment of the patients admitted due to trauma to
      emergency department during the pandemic period.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. The investigators hypothesize that since the number of hospital
      applications expected to be decreased due to trauma during the COVID-19 period, the level of
      hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide
      for the approach, organization, diagnosis and treatment of the patients admitted due to
      trauma to emergency department during the pandemic period.
observational model: Cohort
time perspective: Retrospective
measure: trauma admissions
time frame: 3 months
description: within the study period, trauma patients who admitted to any of the seven study centers will be recorded.
intervention type: Diagnostic Test
intervention name: COVID-19 PCR
description: Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Ramazan Guven
investigator title: Proffessor
mesh term: COVID-19
mesh term: Emergencies
mesh term: Wounds and Injuries
sharing ipd: No