<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/NCT03036540</url>
  </required_header>
  <id_info>
    <org_study_id>UHMotol6022</org_study_id>
    <nct_id>NCT03036540</nct_id>
  </id_info>
  <brief_title>Upper Limb Thrombosis Associated With Midline Catheter</brief_title>
  <official_title>Symptomatic and Asymptomatic Thrombosis in Midline Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Motol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Motol</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 patients admitted in hospital who had midline catheter inserted in upper limb are&#xD;
      followed-up for the presence of complications related to catheter introductions. The symptoms&#xD;
      and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography&#xD;
      examination. In the selected group of asymptomatic patients sonography examination is done 8&#xD;
      to 10 days after cathether insertion in order to detect the incidence of the asymptomatic&#xD;
      thrombosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients admitted in hospital who had midline catheter inserted in upper limb are&#xD;
      followed-up for the presence of complications related to catheter introductions. The symptoms&#xD;
      and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography&#xD;
      examination. The age, gender, principal diagnosis, the vein were midline catheter is inserted&#xD;
      and number of vein punctures for catheter insertion are recorded. Afterward the patients are&#xD;
      treated in the ward and the possible complications are recorded. The main concern is about&#xD;
      the incidence of upper limb thrombosis. All the complications are recorded as well as date&#xD;
      when they has appeared. The statistical analysis is done in order to evaluate the incidence&#xD;
      of upper limb symptomatic thrombosis, the duration since insertion to thrombosis&#xD;
      manifestation ańad its associations with age, gender, principal diagnosis, selected vein, its&#xD;
      size and number of punctures is analysed.&#xD;
&#xD;
      In the selected group of the asymptomatic patients 8 to 10 days after midline insertion upper&#xD;
      limb sonography is done in order to detect the presence of the asymptomatic upper limb&#xD;
      thrombosis and the same type of analysis as for symptomatic thrombosis is undertaken.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter</measure>
    <time_frame>admitted patients in hospital during one year with midline catheter insertion</time_frame>
    <description>The detection of the incidence of upper limb thrombosis and definition of the associated factors</description>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Venous Thrombosis Deep (Limbs)</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>application in midline catheter</intervention_name>
    <description>The routine insertion of midline catheter for the patients admitted in hospital who needs peripheral venous approach for the period more than 5 days or with the insufficient peripheral veins system</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients admitted to University Hospital suffering from disease when venous access is&#xD;
        required for period longer than 5 days or with insufficient peripheral venous access&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients admitted to University Hospital suffering from disease when venous access&#xD;
             is required for period longer than 5 days or with insufficient peripheral venous&#xD;
             access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The patients who need another type of venous access, e.g. central venous access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiri Charvat, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Motol</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiri Charvat, MD, PhD</last_name>
    <phone>+420603280598</phone>
    <email>jiri.charvat@lfmotol.cuni.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katerina Lisova, Mgr</last_name>
    <phone>+420224434005</phone>
    <email>katerina.lisova@fnmotol.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Praga</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiri Charvat, MD,PhD</last_name>
      <phone>+420603280598</phone>
      <email>jiri.charvat@lfmotol.cuni.cz</email>
    </contact>
    <contact_backup>
      <last_name>katerina lisova, Mgr</last_name>
      <phone>+420224434005</phone>
      <email>katerina.lisova@fnmotol.cz</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Motol</investigator_affiliation>
    <investigator_full_name>jiri charvat</investigator_full_name>
    <investigator_title>prof.MD, PhD</investigator_title>
  </responsible_party>
  <keyword>upper limb thrombosis, midline catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The patients with the inseertion of midline catheter during admission in hospital are followed-up for the possible complications including symptoms and signs of symptomatic and asymptomatic upper limb thrombosis using sonography examinations</ipd_description>
  </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/NCT03036540
org study id: UHMotol6022
nct id: NCT03036540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The patients admitted in hospital who had midline catheter inserted in upper limb are
      followed-up for the presence of complications related to catheter introductions. The symptoms
      and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography
      examination. In the selected group of asymptomatic patients sonography examination is done 8
      to 10 days after cathether insertion in order to detect the incidence of the asymptomatic
      thrombosis
The patients admitted in hospital who had midline catheter inserted in upper limb are
      followed-up for the presence of complications related to catheter introductions. The symptoms
      and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography
      examination. The age, gender, principal diagnosis, the vein were midline catheter is inserted
      and number of vein punctures for catheter insertion are recorded. Afterward the patients are
      treated in the ward and the possible complications are recorded. The main concern is about
      the incidence of upper limb thrombosis. All the complications are recorded as well as date
      when they has appeared. The statistical analysis is done in order to evaluate the incidence
      of upper limb symptomatic thrombosis, the duration since insertion to thrombosis
      manifestation ańad its associations with age, gender, principal diagnosis, selected vein, its
      size and number of punctures is analysed.

      In the selected group of the asymptomatic patients 8 to 10 days after midline insertion upper
      limb sonography is done in order to detect the presence of the asymptomatic upper limb
      thrombosis and the same type of analysis as for symptomatic thrombosis is undertaken.
observational model: Cohort
time perspective: Prospective
measure: The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter
time frame: admitted patients in hospital during one year with midline catheter insertion
description: The detection of the incidence of upper limb thrombosis and definition of the associated factors
intervention type: Device
intervention name: application in midline catheter
description: The routine insertion of midline catheter for the patients admitted in hospital who needs peripheral venous approach for the period more than 5 days or with the insufficient peripheral veins system
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiri Charvat, MD,PhD
role: Study Chair
affiliation: University Hospital, Motol
last name: Jiri Charvat, MD, PhD
phone: +420603280598
email: jiri.charvat@lfmotol.cuni.cz
last name: Katerina Lisova, Mgr
phone: +420224434005
email: katerina.lisova@fnmotol.cz
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
country: Czech Republic
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Motol
investigator full name: jiri charvat
investigator title: prof.MD, PhD
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: No
ipd description: The patients with the inseertion of midline catheter during admission in hospital are followed-up for the possible complications including symptoms and signs of symptomatic and asymptomatic upper limb thrombosis using sonography examinations