<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/NCT03021538</url>
  </required_header>
  <id_info>
    <org_study_id>17-166</org_study_id>
    <nct_id>NCT03021538</nct_id>
  </id_info>
  <brief_title>Bypass vs. Ecmo in Lung Transplantation (BELT)</brief_title>
  <acronym>BELT</acronym>
  <official_title>Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during&#xD;
      lung transplant surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will compare use of extracorporeal membrane oxygenation (ECMO) and heart-lung&#xD;
      bypass (CPB) during lung transplant procedures and their short and long term outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Failure to enroll&#xD;
  </why_stopped>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 24, 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>Need for Blood Transfusion</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>Number of pRBC transfusion that resulted due to postoperative bleeding</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Lung Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Cardiopulmonary Bypass</arm_group_label>
    <description>There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extracorporeal Membrane Oxygenation</arm_group_label>
    <description>There will be 40 patients placed on ECMO during lung transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal Membrane Oxygenation</intervention_name>
    <description>ECMO is used during lung transplant procedure</description>
    <arm_group_label>Extracorporeal Membrane Oxygenation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiopulmonary Bypass</intervention_name>
    <description>CPB is used during lung transplant procedure</description>
    <arm_group_label>Cardiopulmonary Bypass</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be all patients requiring cardiopulmonary support while&#xD;
        undergoing lung transplantation at our institution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. The study population will be all patients requiring cardiopulmonary support while&#xD;
        undergoing lung transplantation at our institution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing concomitant cardiac operations with indication for obligate use of&#xD;
             cardiopulmonary bypass&#xD;
&#xD;
          2. Patient with specific anatomy that require full cardiac decompression such as severe&#xD;
             pulmonary hypertension or large heart that are shifted severely into the left chest&#xD;
&#xD;
          3. Patients with high likelihood of significant pleural bleeding that will require&#xD;
             returning the blood back into the cardiotomy reservoir&#xD;
&#xD;
          4. Patients bridged to transplant with ECMO&#xD;
&#xD;
          5. Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to&#xD;
             remove both lungs prior to implantation&#xD;
&#xD;
          6. Patients who the surgeon feels would be better served with CPB rather than ECMO- These&#xD;
             patients will be entered into a registry and followed.&#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>Michael Tong, M.D., M.B.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hoechter DJ, von Dossow V, Winter H, Muller HH, Meiser B, Neurohr C, Behr J, Guenther S, Hagl C, Schramm R. The Munich Lung Transplant Group: Intraoperative Extracorporeal Circulation in Lung Transplantation. Thorac Cardiovasc Surg. 2015 Dec;63(8):706-14. doi: 10.1055/s-0035-1556873. Epub 2015 Aug 20.</citation>
    <PMID>26291747</PMID>
  </reference>
  <reference>
    <citation>Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31.</citation>
    <PMID>22944092</PMID>
  </reference>
  <reference>
    <citation>Bermudez CA, Shiose A, Esper SA, Shigemura N, D'Cunha J, Bhama JK, Richards TJ, Arlia P, Crespo MM, Pilewski JM. Outcomes of intraoperative venoarterial extracorporeal membrane oxygenation versus cardiopulmonary bypass during lung transplantation. Ann Thorac Surg. 2014 Dec;98(6):1936-42; discussion 1942-3. doi: 10.1016/j.athoracsur.2014.06.072. Epub 2014 Oct 22.</citation>
    <PMID>25443002</PMID>
  </reference>
  <reference>
    <citation>Machuca TN, Collaud S, Mercier O, Cheung M, Cunningham V, Kim SJ, Azad S, Singer L, Yasufuku K, de Perrot M, Pierre A, McRae K, Waddell TK, Keshavjee S, Cypel M. Outcomes of intraoperative extracorporeal membrane oxygenation versus cardiopulmonary bypass for lung transplantation. J Thorac Cardiovasc Surg. 2015 Apr;149(4):1152-7. doi: 10.1016/j.jtcvs.2014.11.039. Epub 2014 Nov 21.</citation>
    <PMID>25583107</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>February 24, 2020</results_first_submitted>
  <results_first_submitted_qc>March 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2020</results_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Michael Zhen-Yu Tong, MD</investigator_full_name>
    <investigator_title>Cardiac Surgeon</investigator_title>
  </responsible_party>
  <keyword>Cardiopulmonary Bypass</keyword>
  <keyword>Extracorporeal Membrane Oxygenation</keyword>
  <keyword>Primary Graft Dysfunction</keyword>
  <keyword>Hemorrhage</keyword>
  <keyword>Mechanical Ventilator</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03021538/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cardiopulmonary Bypass</title>
          <description>There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.&#xD;
Cardiopulmonary Bypass: CPB is used during lung transplant procedure</description>
        </group>
        <group group_id="P2">
          <title>Extracorporeal Membrane Oxygenation</title>
          <description>There will be 40 patients placed on ECMO during lung transplantation.&#xD;
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cardiopulmonary Bypass</title>
          <description>There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.&#xD;
Cardiopulmonary Bypass: CPB is used during lung transplant procedure</description>
        </group>
        <group group_id="B2">
          <title>Extracorporeal Membrane Oxygenation</title>
          <description>There will be 40 patients randomized to ECMO during lung transplantation.&#xD;
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure</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="6"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="13"/>
          </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="6"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                  </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="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" spread="7"/>
                    <measurement group_id="B2" value="54" spread="9"/>
                    <measurement group_id="B3" value="60" spread="10"/>
                  </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="6"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Need for Blood Transfusion</title>
        <description>Number of pRBC transfusion that resulted due to postoperative bleeding</description>
        <time_frame>72 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardiopulmonary Bypass</title>
            <description>There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.&#xD;
Cardiopulmonary Bypass: CPB is used during lung transplant procedure</description>
          </group>
          <group group_id="O2">
            <title>Extracorporeal Membrane Oxygenation</title>
            <description>There will be 40 patients randomized to ECMO during lung transplantation.&#xD;
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Need for Blood Transfusion</title>
          <description>Number of pRBC transfusion that resulted due to postoperative bleeding</description>
          <units>number of pRBC transfusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="6.1"/>
                    <measurement group_id="O2" value="6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to hospital discharge</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cardiopulmonary Bypass</title>
          <description>There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.&#xD;
Cardiopulmonary Bypass: CPB is used during lung transplant procedure</description>
        </group>
        <group group_id="E2">
          <title>Extracorporeal Membrane Oxygenation</title>
          <description>There will be 40 patients placed on ECMO during lung transplantation.&#xD;
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure</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="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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>
    <point_of_contact>
      <name_or_title>Michael Tong, M. D.</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-445-0807</phone>
      <email>tongz@ccf.org</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/NCT03021538
org study id: 17-166
nct id: NCT03021538
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during
      lung transplant surgeries.
This study will compare use of extracorporeal membrane oxygenation (ECMO) and heart-lung
      bypass (CPB) during lung transplant procedures and their short and long term outcomes.
observational model: Cohort
time perspective: Prospective
measure: Need for Blood Transfusion
time frame: 72 hours after surgery
description: Number of pRBC transfusion that resulted due to postoperative bleeding
arm group label: Cardiopulmonary Bypass
description: There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
arm group label: Extracorporeal Membrane Oxygenation
description: There will be 40 patients placed on ECMO during lung transplantation.
intervention type: Device
intervention name: Extracorporeal Membrane Oxygenation
description: ECMO is used during lung transplant procedure
arm group label: Extracorporeal Membrane Oxygenation
intervention type: Device
intervention name: Cardiopulmonary Bypass
description: CPB is used during lung transplant procedure
arm group label: Cardiopulmonary Bypass
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Tong, M.D., M.B.A.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Hoechter DJ, von Dossow V, Winter H, Muller HH, Meiser B, Neurohr C, Behr J, Guenther S, Hagl C, Schramm R. The Munich Lung Transplant Group: Intraoperative Extracorporeal Circulation in Lung Transplantation. Thorac Cardiovasc Surg. 2015 Dec;63(8):706-14. doi: 10.1055/s-0035-1556873. Epub 2015 Aug 20.
PMID: 26291747
citation: Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31.
PMID: 22944092
citation: Bermudez CA, Shiose A, Esper SA, Shigemura N, D'Cunha J, Bhama JK, Richards TJ, Arlia P, Crespo MM, Pilewski JM. Outcomes of intraoperative venoarterial extracorporeal membrane oxygenation versus cardiopulmonary bypass during lung transplantation. Ann Thorac Surg. 2014 Dec;98(6):1936-42; discussion 1942-3. doi: 10.1016/j.athoracsur.2014.06.072. Epub 2014 Oct 22.
PMID: 25443002
citation: Machuca TN, Collaud S, Mercier O, Cheung M, Cunningham V, Kim SJ, Azad S, Singer L, Yasufuku K, de Perrot M, Pierre A, McRae K, Waddell TK, Keshavjee S, Cypel M. Outcomes of intraoperative extracorporeal membrane oxygenation versus cardiopulmonary bypass for lung transplantation. J Thorac Cardiovasc Surg. 2015 Apr;149(4):1152-7. doi: 10.1016/j.jtcvs.2014.11.039. Epub 2014 Nov 21.
PMID: 25583107
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Michael Zhen-Yu Tong, MD
investigator title: Cardiac Surgeon
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 