<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/NCT01670188</url>
  </required_header>
  <id_info>
    <org_study_id>12-004676</org_study_id>
    <nct_id>NCT01670188</nct_id>
  </id_info>
  <brief_title>SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines</brief_title>
  <official_title>Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to see if a compression device on the arm where a peripherally&#xD;
      inserted central catheter (PICC) line has been inserted can prevent the formation of a blood&#xD;
      clot around the PICC line.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a pilot prospective randomized controlled trial, consecutive patients requiring placement&#xD;
      of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the&#xD;
      SCD (intervention) group or a non SCD (control) group.&#xD;
&#xD;
      Standardized vascular access patency protocols was used in all enrolled patients. All&#xD;
      patients had an indwelling 5 French, double lumen PICC unless additional venous access was&#xD;
      required by the primary service. Patients randomized to the intervention arm had an SCD&#xD;
      placed in the arm with the PICC within 24 hours of PICC placement.&#xD;
&#xD;
      Five to seven days after placement of the PICC, the patients were examined with venous duplex&#xD;
      ultrasound of the upper extremity to assess for the presence of venous thrombosis. The&#xD;
      patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for&#xD;
      more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity&#xD;
      ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous&#xD;
      thromboembolism, the investigations were performed according to current practice standards.&#xD;
      Data collection was be considered complete upon removal of the PICC line.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis: patients treated with SCD had higher incidence of DVT.&#xD;
  </why_stopped>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">October 13, 2016</completion_date>
  <primary_completion_date type="Actual">October 13, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis</measure>
    <time_frame>baseline to 14 days post insertion of PICC line</time_frame>
    <description>Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Deep Vein Thrombosis</condition>
  <arm_group>
    <arm_group_label>Pneumatic SCD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-SCD group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pneumatic SCD - VenaFlow System (DJO Global)</intervention_name>
    <arm_group_label>Pneumatic SCD</arm_group_label>
    <other_name>VenaFlow System (DJO Global)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject's age is greater than or equal to 18 years&#xD;
&#xD;
          -  Subject is patient in neuro intensive care unit at time of PICC placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute trauma to the upper extremity harboring the PICC&#xD;
&#xD;
          -  Current use of prophylactic anticoagulation&#xD;
&#xD;
          -  Inability to fit the SCD on the arm because of arm size&#xD;
&#xD;
          -  Documented previous upper extremity DVT in the arm harboring the PICC line&#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>Alejandro Rabinstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>December 12, 2017</results_first_submitted>
  <results_first_submitted_qc>December 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2018</results_first_posted>
  <last_update_submitted>December 12, 2017</last_update_submitted>
  <last_update_submitted_qc>December 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Alejandro Rabinstein</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Pneumatic sequential compression device (SCD)</keyword>
  <keyword>Peripherally Inserted Central Catheters (PICC)</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients requiring placement of a peripherally inserted central catheter (PICC) line in the neuroscience intensive care unit were recruited at Mayo Clinic in Rochester, Minnesota.</recruitment_details>
      <pre_assignment_details>One patient randomized to the non-SCD arm died before the first ultrasound could be obtained and therefore could not be entered into the analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pneumatic SCD</title>
          <description>Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.</description>
        </group>
        <group group_id="P2">
          <title>Non-SCD Group</title>
          <description>Patients enrolled in this group received standard care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pneumatic SCD</title>
          <description>Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.</description>
        </group>
        <group group_id="B2">
          <title>Non-SCD Group</title>
          <description>Patients enrolled in this group received standard care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis</title>
        <description>Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter</description>
        <time_frame>baseline to 14 days post insertion of PICC line</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pneumatic SCD</title>
            <description>Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.</description>
          </group>
          <group group_id="O2">
            <title>Non-SCD Group</title>
            <description>Patients enrolled in this group received standard care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis</title>
          <description>Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pneumatic SCD</title>
          <description>Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.</description>
        </group>
        <group group_id="E2">
          <title>Non-SCD Group</title>
          <description>Patients enrolled in this group received standard care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early because the pre-determined interim analysis showed patients treated with the SCD had higher incidence of DVT by ultrasound.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Alejandro Rabinstein</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-4741</phone>
      <email>Rabinstein.Alejandro@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01670188
org study id: 12-004676
nct id: NCT01670188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to see if a compression device on the arm where a peripherally
      inserted central catheter (PICC) line has been inserted can prevent the formation of a blood
      clot around the PICC line.
In a pilot prospective randomized controlled trial, consecutive patients requiring placement
      of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the
      SCD (intervention) group or a non SCD (control) group.

      Standardized vascular access patency protocols was used in all enrolled patients. All
      patients had an indwelling 5 French, double lumen PICC unless additional venous access was
      required by the primary service. Patients randomized to the intervention arm had an SCD
      placed in the arm with the PICC within 24 hours of PICC placement.

      Five to seven days after placement of the PICC, the patients were examined with venous duplex
      ultrasound of the upper extremity to assess for the presence of venous thrombosis. The
      patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for
      more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity
      ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous
      thromboembolism, the investigations were performed according to current practice standards.
      Data collection was be considered complete upon removal of the PICC line.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
time frame: baseline to 14 days post insertion of PICC line
description: Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
arm group label: Pneumatic SCD
arm group type: Active Comparator
description: Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
arm group label: Non-SCD group
arm group type: No Intervention
description: Standard care
intervention type: Device
intervention name: Pneumatic SCD - VenaFlow System (DJO Global)
arm group label: Pneumatic SCD
other name: VenaFlow System (DJO Global)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alejandro Rabinstein, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Alejandro Rabinstein
investigator title: PI
mesh term: Thrombosis
mesh term: Venous Thrombosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early because the pre-determined interim analysis showed patients treated with the SCD had higher incidence of DVT by ultrasound.
point of contact: 