<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/NCT04455373</url>
  </required_header>
  <id_info>
    <org_study_id>1025/2018</org_study_id>
    <nct_id>NCT04455373</nct_id>
  </id_info>
  <brief_title>Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection</brief_title>
  <official_title>Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Introduction:&#xD;
&#xD;
      Vascular bypass surgery in children differs significantly from adults. It is a rarely&#xD;
      performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage.&#xD;
      Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting&#xD;
      should not impede growth of the extremity. The primary aim of this study was to assess&#xD;
      long-term outcome after pediatric bypass grafting, in a single academic center, focusing on&#xD;
      potential effects on limb development.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      In this retrospective cohort analyses we included all pediatric patients undergoing vascular&#xD;
      bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18&#xD;
      years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb,&#xD;
      respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5&#xD;
      years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2002</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>bypass growth</measure>
    <time_frame>10 years</time_frame>
    <description>bypass growth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>autologous vs. PTFE graft</measure>
    <time_frame>patency rate in 1 year</time_frame>
    <description>patients will either receive an autologous bypass graft or PTFE graft</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>revision surgery</measure>
    <time_frame>&lt;30 days</time_frame>
    <description>revision surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Child Health</condition>
  <condition>Bypass Graft Occlusion</condition>
  <arm_group>
    <arm_group_label>orthopedic surgery group</arm_group_label>
    <description>Planned tumor resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traumatic surgery group</arm_group_label>
    <description>Patients with traumatic vascular injury</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pediatric vascular bypass grafting</intervention_name>
    <description>pediatric vascular bypass grafting</description>
    <arm_group_label>orthopedic surgery group</arm_group_label>
    <arm_group_label>traumatic surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study represents a retrospective cohort analysis of pediatric patients who underwent&#xD;
        vascular bypass grafting by an experienced team of vascular surgeons at the Medical&#xD;
        University Vienna between 2002-2017.&#xD;
&#xD;
        All data regarding demographics, operative techniques and outcome were collected from the&#xD;
        in-hospital database registry in collaboration with the Department of Orthopedics and&#xD;
        Trauma-Surgery. All patients ≤ 18 years who suffered a traumatic injury or vascular surgery&#xD;
        due to a planned orthopedic extremity tumor resection were included in this study. 33&#xD;
        patients underwent vascular repair, a total of 15 patients fulfilling the criteria could be&#xD;
        identified.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  planned vascular bypass grafting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  no vascular intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Stephanie Kampf, MD</investigator_full_name>
    <investigator_title>Long-term outcome in pediatric surgical bypass grafting after traumatic injury and tumor resection</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04455373
org study id: 1025/2018
nct id: NCT04455373
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Vascular bypass surgery in children differs significantly from adults. It is a rarely
      performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage.
      Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting
      should not impede growth of the extremity. The primary aim of this study was to assess
      long-term outcome after pediatric bypass grafting, in a single academic center, focusing on
      potential effects on limb development.

      Methods:

      In this retrospective cohort analyses we included all pediatric patients undergoing vascular
      bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18
      years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb,
      respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5
      years.
observational model: Cohort
time perspective: Retrospective
measure: bypass growth
time frame: 10 years
description: bypass growth
measure: autologous vs. PTFE graft
time frame: patency rate in 1 year
description: patients will either receive an autologous bypass graft or PTFE graft
measure: revision surgery
time frame: <30 days
description: revision surgery
arm group label: orthopedic surgery group
description: Planned tumor resection
arm group label: traumatic surgery group
description: Patients with traumatic vascular injury
intervention type: Procedure
intervention name: pediatric vascular bypass grafting
description: pediatric vascular bypass grafting
arm group label: orthopedic surgery group
arm group label: traumatic surgery group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Stephanie Kampf, MD
investigator title: Long-term outcome in pediatric surgical bypass grafting after traumatic injury and tumor resection
mesh term: Wounds and Injuries
sharing ipd: No