xml: <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/NCT05977452</url>
    </required_header>
    <id_info>
      <org_study_id>SunYat-senU 7-18</org_study_id>
      <nct_id>NCT05977452</nct_id>
    </id_info>
    <brief_title>The Risk Assessment Scale for Peripherally Inserted Central Venous Catheter (PICC) Related Thrombosis in Cancer Patients</brief_title>
    <official_title>The Risk Assessment Scale for Peripherally Inserted Central Venous Catheter (PICC) Related Thrombosis in Cancer Patients :A Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to compare the accuracy and clinical predictive value of the&#xD;
        Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale （Chinese version）in&#xD;
        predicting PICC-related thrombosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to compare the accuracy and clinical predictive value of the&#xD;
        Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale（Chinese version） in&#xD;
        predicting PICC-related thrombosis.&#xD;
  &#xD;
        Patients who will receive PICC placement will be evaluated by using the Michigan Risk Score,&#xD;
        Caprini Risk Assessment Model , and Maneval Scale the day during PICC placement, 24-48h after&#xD;
        PICC placement and every time patients receive PICC maintenance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>PICC thrombosis</measure>
      <time_frame>through study completion，up to 1 year</time_frame>
      <description>symptomatic thrombosis，diagnosed by symptoms such as pain, tenderness and swelling of the affected part and the verification of color doppler ultrasound of venous vessels</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Michigan Risk Score</measure>
      <time_frame>From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.</time_frame>
      <description>The risk score will be assessed. In this scale，risk factors associated with PICC-DVT included: history of DVT; multi-lumen PICC; active cancer; presence of another CVC when the PICC was placed; and white blood cell count greater than 12 000. The total score on the scale are 0 to 14 points, with a higher score indicates higher risk of thrombosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maneval Scale</measure>
      <time_frame>From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.</time_frame>
      <description>The risk score will be assessed. This scale includes 45 risk factors associated with PICC thrombosis. The total score on the scale are 0 to 45 points, with a higher score indicates higher risk of thrombosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Caprini Risk Assessment Model</measure>
      <time_frame>From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.</time_frame>
      <description>The risk score will be assessed. This scale includes more than 40 risk factors associated with PICC thrombosis. In this scale，a higher score indicates higher risk of thrombosis.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">281</enrollment>
    <condition>Thrombosis</condition>
    <condition>Catheter</condition>
    <arm_group>
      <arm_group_label>patients with PICC placement</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale</intervention_name>
      <description>Patients with PICC placement will be assessed by the Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale（Chinese version） to predict the risk of PICC-related thrombosis. The time of evaluation are the day during PICC placement, 24-48h after PICC placement, and every time when patients receive PICC maintenance.</description>
      <arm_group_label>patients with PICC placement</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          cancer patients with PICC placement in Sun Yat-sen University Cancer Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cancer patients&#xD;
  &#xD;
            -  Older than 18 years&#xD;
  &#xD;
            -  Being able to complete the questionnaire independently&#xD;
  &#xD;
            -  Patients who need PICC for treatment&#xD;
  &#xD;
            -  Being able to perform catheter maintenance in the hospital of admission until catheter&#xD;
               removal&#xD;
  &#xD;
            -  Patients who agree to participate and sign the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who were or suspected to be allergic to the ingredients contained in PICC&#xD;
  &#xD;
            -  PICC placed in the lower extremity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Zeyin Hu</last_name>
      <phone>020-87343354</phone>
      <email>huzy@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Catheter Clinic</name>
        <address>
          <city>Guangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zeyin Hu</last_name>
        <phone>02087343354</phone>
        <email>huzy@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Zeyin Hu</investigator_full_name>
      <investigator_title>Infusion Therapy Specialist Nurse</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977452
  org study id: SunYat-senU 7-18
  nct id: NCT05977452
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare the accuracy and clinical predictive value of the
        Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale （Chinese version）in
        predicting PICC-related thrombosis.
  The aim of this study is to compare the accuracy and clinical predictive value of the
        Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale（Chinese version） in
        predicting PICC-related thrombosis.
  
        Patients who will receive PICC placement will be evaluated by using the Michigan Risk Score,
        Caprini Risk Assessment Model , and Maneval Scale the day during PICC placement, 24-48h after
        PICC placement and every time patients receive PICC maintenance.
  observational model: Cohort
  time perspective: Prospective
  measure: PICC thrombosis
  time frame: through study completion，up to 1 year
  description: symptomatic thrombosis，diagnosed by symptoms such as pain, tenderness and swelling of the affected part and the verification of color doppler ultrasound of venous vessels
  measure: The Michigan Risk Score
  time frame: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.
  description: The risk score will be assessed. In this scale，risk factors associated with PICC-DVT included: history of DVT; multi-lumen PICC; active cancer; presence of another CVC when the PICC was placed; and white blood cell count greater than 12 000. The total score on the scale are 0 to 14 points, with a higher score indicates higher risk of thrombosis.
  measure: Maneval Scale
  time frame: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.
  description: The risk score will be assessed. This scale includes 45 risk factors associated with PICC thrombosis. The total score on the scale are 0 to 45 points, with a higher score indicates higher risk of thrombosis.
  measure: Caprini Risk Assessment Model
  time frame: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.
  description: The risk score will be assessed. This scale includes more than 40 risk factors associated with PICC thrombosis. In this scale，a higher score indicates higher risk of thrombosis.
  arm group label: patients with PICC placement
  intervention type: Diagnostic Test
  intervention name: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale
  description: Patients with PICC placement will be assessed by the Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale（Chinese version） to predict the risk of PICC-related thrombosis. The time of evaluation are the day during PICC placement, 24-48h after PICC placement, and every time when patients receive PICC maintenance.
  arm group label: patients with PICC placement
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 80 Years
  last name: Zeyin Hu
  phone: 020-87343354
  email: huzy@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Zeyin Hu
  investigator title: Infusion Therapy Specialist Nurse
  mesh term: Thrombosis
  sharing ipd: Undecided