<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/NCT03276403</url>
  </required_header>
  <id_info>
    <org_study_id>1618/2016</org_study_id>
    <nct_id>NCT03276403</nct_id>
  </id_info>
  <brief_title>Primary Graft Dysfunction Score in Lung Transplantation</brief_title>
  <official_title>Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The validity of several functional parameters, which could be included in a new PGD scoring&#xD;
      system, will be tested in a prospective pilot study of 80 consecutive bilateral lung&#xD;
      transplant recipients in high volume lung transplant centers. Functional parameters will be&#xD;
      collected at different time points within the first 72hrs after lung transplantation and&#xD;
      their accuracy in predicting clinical outcome as well as their correlation with lung water&#xD;
      content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a&#xD;
      novel PGD score), which can then be tested in future prospective trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary graft dysfunction</measure>
    <time_frame>72 hours after transplantation</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Lung Transplant; Complications</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PiCCO Catheter</intervention_name>
    <description>The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving double lung transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic&#xD;
             fibrosis (CF), Emphysema&#xD;
&#xD;
          -  No restrictions regarding donor lungs (marginal donors, EVLP possible)&#xD;
&#xD;
          -  No restrictions regarding size reduction (anatomic wedge resections, three lobar,&#xD;
             lobar transplantations)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Single-lung transplantation&#xD;
&#xD;
          -  Heart-lung transplantation&#xD;
&#xD;
          -  Re-transplantation&#xD;
&#xD;
          -  Patients with bridge-to-transplantation with a mechanical assist device&#xD;
             (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)&#xD;
&#xD;
          -  Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts,&#xD;
             significant tricuspid regurgitation, cooling&#xD;
&#xD;
          -  No access to the femoral artery possible&#xD;
&#xD;
          -  Severe postoperative hemorrhage, which leads to hematothorax and makes revision&#xD;
             surgery necessary&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Konrad Hoetzenecker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Konrad Hoetzenecker, MD, PhD</last_name>
    <phone>0043140400</phone>
    <phone_ext>56990</phone_ext>
    <email>konrad.hoetzenecker@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas Schweiger, MD, PhD</last_name>
    <phone>0043140400</phone>
    <phone_ext>56990</phone_ext>
    <email>thomas.schweiger@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Konrad Hoetzenecker, MD,PhD</last_name>
      <phone>0043140400</phone>
      <phone_ext>56990</phone_ext>
      <email>konrad.hoetzenecker@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Thomas Schweiger, MD,PhD</last_name>
      <phone>0043140400</phone>
      <phone_ext>56990</phone_ext>
      <email>thomas.schweiger@meduniwien.ac.at</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaf Keshavjee, MD, MSc</last_name>
      <phone>001416340</phone>
      <phone_ext>3863</phone_ext>
      <email>shaf.keshavjee@uhn.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD</investigator_full_name>
    <investigator_title>Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Graft Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD will be shared upon request</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/NCT03276403
org study id: 1618/2016
nct id: NCT03276403
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The validity of several functional parameters, which could be included in a new PGD scoring
      system, will be tested in a prospective pilot study of 80 consecutive bilateral lung
      transplant recipients in high volume lung transplant centers. Functional parameters will be
      collected at different time points within the first 72hrs after lung transplantation and
      their accuracy in predicting clinical outcome as well as their correlation with lung water
      content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a
      novel PGD score), which can then be tested in future prospective trials.
observational model: Cohort
time perspective: Prospective
measure: Primary graft dysfunction
time frame: 72 hours after transplantation
intervention type: Device
intervention name: PiCCO Catheter
description: The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Konrad Hoetzenecker, MD, PhD
role: Principal Investigator
affiliation: Medical University of Vienna
last name: Konrad Hoetzenecker, MD, PhD
phone: 0043140400
phone ext: 56990
email: konrad.hoetzenecker@meduniwien.ac.at
last name: Thomas Schweiger, MD, PhD
phone: 0043140400
phone ext: 56990
email: thomas.schweiger@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Austria
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD
investigator title: Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD
mesh term: Primary Graft Dysfunction
sharing ipd: Undecided
ipd description: IPD will be shared upon request