<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/NCT04452682</url>
  </required_header>
  <id_info>
    <org_study_id>R.20.06.898 - 2020/06/16</org_study_id>
    <nct_id>NCT04452682</nct_id>
  </id_info>
  <brief_title>The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice</brief_title>
  <official_title>The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a retrospective analytical study conducted at Vascular and Endovascular surgery&#xD;
      Department, Mansoura University Hospital, including all patients admitted at the two periods&#xD;
      first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the&#xD;
      practice of emergency vascular surgery and critical limb threatening ischemia interventions&#xD;
      by comparison two periods first six months of 2019 and 2020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      The novel coronavirus pneumonia (COVID-19) pandemic has affected the globe, with Italy&#xD;
      leading many reports of the incidence and mortalities. Recently reported studies have&#xD;
      described the clinical characteristics and overall outcomes of patients with COVID-19 and the&#xD;
      effects of treating these patients on the healthcare system.Two studies have reported&#xD;
      associated coagulopathy disorders. These reports have highlighted the presence of a&#xD;
      coexisting hypercoagulable state in patients with COVID-19, which might be associated with&#xD;
      higher mortality.&#xD;
&#xD;
      The COVID-19 pandemic has had many impacts, both seen and unforeseen, all over the world. As&#xD;
      expected, elective endovascular procedures have been halted, with a significant decrease in&#xD;
      urgent/emergent procedures. This could reflect an understandable unwillingness on the part of&#xD;
      patients who continue to self-isolate at home to come in for treatments, including those with&#xD;
      Critical limb threatening ischemia. Also impacts on the supply chain side of performing&#xD;
      interventions, had been reported, it is challenging to be in the middle of a complex CLTI&#xD;
      (Critical limb threatening ischemia) case and request a routine device only to find out it is&#xD;
      unavailable.&#xD;
&#xD;
      Aim of the work Evaluation the impact of COVID-19 pandemic on emergency vascular practice and&#xD;
      critical limb ischemia.&#xD;
&#xD;
      Outcome&#xD;
&#xD;
      Primary outcomes:&#xD;
&#xD;
        -  Frequencies of patients admitted at the Vascular.&#xD;
&#xD;
        -  Predisposing Factors.&#xD;
&#xD;
        -  Number of ICU admission.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      • Mortality rates&#xD;
&#xD;
      Patients and methods Study location: The study will be conducted at the department of&#xD;
      vascular surgery in Mansoura university hospitals Type of study: Observational analytical&#xD;
      study Study duration: 2019-2020 Sample size: It will include all patients presented to our&#xD;
      department at the first 6 months of 2019 and first 6 months of 2020. sample size will be&#xD;
      140-400 patients Inclusion criteria: all patients admitted to our department at that periods&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. Patients can't give consent (unconscious).&#xD;
&#xD;
        2. Those with mental or behavioral disorders will be excluded. Consent: Patients after&#xD;
           signing informed consent that possible complication from the procedure ought to happen&#xD;
           and what are the alternatives.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
        -  All patients with complete medical records available will be documented&#xD;
&#xD;
        -  Each patient's record will be analyzed to determine preexisting illnesses, admitting&#xD;
           symptoms (including length of time to accessing medical care), admission physical&#xD;
           findings, laboratory and results.&#xD;
&#xD;
        -  Also, the type and duration of antibiotic therapy, the frequency and type of operative&#xD;
           procedures performed and subsequent complications.&#xD;
&#xD;
        -  Supporting modalities such as dialysis, blood product transfusion, and mechanical&#xD;
           ventilation will be were reviewed.&#xD;
&#xD;
        -  Each patient's premorbid medical profile, condition at admission, and subsequent&#xD;
           treatment also will be analyzed to assess effect on mortality and development of&#xD;
           complications.&#xD;
&#xD;
        -  Standard treatment after admission including cardiovascular stabilization and assessment&#xD;
           of extent of infection. Broad-spectrum antibiotics were administered to cover&#xD;
           gram-positive cocci, gram-negative enteric rods, and anaerobic flora will be also&#xD;
           reported.&#xD;
&#xD;
        -  The procedure of Surgical Management will be described.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      · The data will be analyzed using Statistical Package for the Social Sciences. The numerical&#xD;
      outcomes e.g. age is calculated as median. Gender will be recorded as frequency and&#xD;
      percentage. Chi Square test is applied to assess the association of various parameters. The&#xD;
      results will be considered statistically significant if the p-value is found to be less than&#xD;
      or equal to 0.05. To assess possible risk factors for mortality, univariate analyses will be&#xD;
      completed initially to aid in determining the variables that should be included in a stepwise&#xD;
      logistic regression model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">June 21, 2020</completion_date>
  <primary_completion_date type="Actual">June 21, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The ICU admission with associated Pneumonia</measure>
    <time_frame>6 months</time_frame>
    <description>The ICU admission caused by Pneumonia proved radio-logically at both periods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of COVID-19 on the different presentation of vascular surgery at the emergency</measure>
    <time_frame>6 months</time_frame>
    <description>percentage of different diagnoses at both periods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rates</measure>
    <time_frame>6 months</time_frame>
    <description>Mortality percentages at both periods</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">998</enrollment>
  <condition>COVID</condition>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Era of COVID 19</arm_group_label>
    <description>Total number of cases admitted during first six months of 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Era of Non COVID 19</arm_group_label>
    <description>Total number of cases admitted the first six months of 2019</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID 19 impact</intervention_name>
    <description>The impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice</description>
    <arm_group_label>Era of COVID 19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        It will include all patients presented to our department at the first 6 months of 2019 and&#xD;
        first 6 months of 2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to our department at that periods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients can't give consent (unconscious).&#xD;
&#xD;
          -  Those with mental or behavioral disorders will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Mansoura university</name>
      <address>
        <city>Mansoura</city>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Ischemia</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/NCT04452682
org study id: R.20.06.898 - 2020/06/16
nct id: NCT04452682
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a retrospective analytical study conducted at Vascular and Endovascular surgery
      Department, Mansoura University Hospital, including all patients admitted at the two periods
      first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the
      practice of emergency vascular surgery and critical limb threatening ischemia interventions
      by comparison two periods first six months of 2019 and 2020.
INTRODUCTION:

      The novel coronavirus pneumonia (COVID-19) pandemic has affected the globe, with Italy
      leading many reports of the incidence and mortalities. Recently reported studies have
      described the clinical characteristics and overall outcomes of patients with COVID-19 and the
      effects of treating these patients on the healthcare system.Two studies have reported
      associated coagulopathy disorders. These reports have highlighted the presence of a
      coexisting hypercoagulable state in patients with COVID-19, which might be associated with
      higher mortality.

      The COVID-19 pandemic has had many impacts, both seen and unforeseen, all over the world. As
      expected, elective endovascular procedures have been halted, with a significant decrease in
      urgent/emergent procedures. This could reflect an understandable unwillingness on the part of
      patients who continue to self-isolate at home to come in for treatments, including those with
      Critical limb threatening ischemia. Also impacts on the supply chain side of performing
      interventions, had been reported, it is challenging to be in the middle of a complex CLTI
      (Critical limb threatening ischemia) case and request a routine device only to find out it is
      unavailable.

      Aim of the work Evaluation the impact of COVID-19 pandemic on emergency vascular practice and
      critical limb ischemia.

      Outcome

      Primary outcomes:

        -  Frequencies of patients admitted at the Vascular.

        -  Predisposing Factors.

        -  Number of ICU admission.

      Secondary outcomes:

      • Mortality rates

      Patients and methods Study location: The study will be conducted at the department of
      vascular surgery in Mansoura university hospitals Type of study: Observational analytical
      study Study duration: 2019-2020 Sample size: It will include all patients presented to our
      department at the first 6 months of 2019 and first 6 months of 2020. sample size will be
      140-400 patients Inclusion criteria: all patients admitted to our department at that periods
      Exclusion criteria

        1. Patients can't give consent (unconscious).

        2. Those with mental or behavioral disorders will be excluded. Consent: Patients after
           signing informed consent that possible complication from the procedure ought to happen
           and what are the alternatives.

      Data collection:

        -  All patients with complete medical records available will be documented

        -  Each patient's record will be analyzed to determine preexisting illnesses, admitting
           symptoms (including length of time to accessing medical care), admission physical
           findings, laboratory and results.

        -  Also, the type and duration of antibiotic therapy, the frequency and type of operative
           procedures performed and subsequent complications.

        -  Supporting modalities such as dialysis, blood product transfusion, and mechanical
           ventilation will be were reviewed.

        -  Each patient's premorbid medical profile, condition at admission, and subsequent
           treatment also will be analyzed to assess effect on mortality and development of
           complications.

        -  Standard treatment after admission including cardiovascular stabilization and assessment
           of extent of infection. Broad-spectrum antibiotics were administered to cover
           gram-positive cocci, gram-negative enteric rods, and anaerobic flora will be also
           reported.

        -  The procedure of Surgical Management will be described.

      Statistical analysis

      · The data will be analyzed using Statistical Package for the Social Sciences. The numerical
      outcomes e.g. age is calculated as median. Gender will be recorded as frequency and
      percentage. Chi Square test is applied to assess the association of various parameters. The
      results will be considered statistically significant if the p-value is found to be less than
      or equal to 0.05. To assess possible risk factors for mortality, univariate analyses will be
      completed initially to aid in determining the variables that should be included in a stepwise
      logistic regression model.
observational model: Case-Only
time perspective: Retrospective
measure: The ICU admission with associated Pneumonia
time frame: 6 months
description: The ICU admission caused by Pneumonia proved radio-logically at both periods
measure: Impact of COVID-19 on the different presentation of vascular surgery at the emergency
time frame: 6 months
description: percentage of different diagnoses at both periods
measure: Mortality rates
time frame: 6 months
description: Mortality percentages at both periods
arm group label: Era of COVID 19
description: Total number of cases admitted during first six months of 2020
arm group label: Era of Non COVID 19
description: Total number of cases admitted the first six months of 2019
intervention type: Other
intervention name: COVID 19 impact
description: The impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice
arm group label: Era of COVID 19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Emergencies
mesh term: Ischemia
sharing ipd: No