<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/NCT03818113</url>
  </required_header>
  <id_info>
    <org_study_id>2019-00070; ch18Grapow4</org_study_id>
    <nct_id>NCT03818113</nct_id>
  </id_info>
  <brief_title>Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy</brief_title>
  <official_title>Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in&#xD;
      cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a&#xD;
      crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).&#xD;
&#xD;
      This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding&#xD;
      peri- and postoperative outcome, especially for cardiac biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>high specific troponin T (hs-TrT) (μg/l)</measure>
    <time_frame>perioperative during minimal invasive surgery</time_frame>
    <description>cardial biomarker for myocardial damage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatin-Phosphokinase (CK) (U/l)</measure>
    <time_frame>perioperative during minimal invasive surgery</time_frame>
    <description>cardial biomarker for myocardial damage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinkinase Muscle- Brain (CK-MB) (U/l)</measure>
    <time_frame>perioperative during minimal invasive surgery</time_frame>
    <description>cardial biomarker for myocardial damage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>from minimal invasive surgery until 30 days post surgery</time_frame>
    <description>number of deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay in intensive care unit (days)</measure>
    <time_frame>from minimal invasive surgery until 30 days post surgery</time_frame>
    <description>length of stay in intensive care unit (number of days)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Mitral Valve Reconstruction</condition>
  <arm_group>
    <arm_group_label>HTK-Bretschneider cardioplegic solution</arm_group_label>
    <description>Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>St. Thomas cardioplegic solution</arm_group_label>
    <description>Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardioplegia with HTK-Bretschneider cardioplegic solution</intervention_name>
    <description>cardioplegia with HTK-Bretschneider cardioplegic solution</description>
    <arm_group_label>HTK-Bretschneider cardioplegic solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardioplegia with St. Thomas cardioplegic solution</intervention_name>
    <description>cardioplegia with St. Thomas cardioplegic solution</description>
    <arm_group_label>St. Thomas cardioplegic solution</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with mitral valve reconstruction done via minimal invasive antero- lateral&#xD;
        thoracotomy (2009-2018) at Universitätsspital Basel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in&#xD;
             cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a&#xD;
             crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular&#xD;
             solution).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in&#xD;
             cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a&#xD;
             crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular&#xD;
             solution).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Grapow, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Herzchirurgie, Universitätsspital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Herzchirurgie, Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitral valve insufficiency</keyword>
  <keyword>cardioplegia</keyword>
  <keyword>cardioplegia Solution</keyword>
  <keyword>HTK-Bretschneider (Custidiol®) solution</keyword>
  <keyword>St. Thomas solution</keyword>
  <keyword>cardiac biomarker</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardioplegic Solutions</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03818113
org study id: 2019-00070; ch18Grapow4
nct id: NCT03818113
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in
      cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a
      crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

      This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding
      peri- and postoperative outcome, especially for cardiac biomarkers.
observational model: Cohort
time perspective: Retrospective
measure: high specific troponin T (hs-TrT) (μg/l)
time frame: perioperative during minimal invasive surgery
description: cardial biomarker for myocardial damage
measure: Creatin-Phosphokinase (CK) (U/l)
time frame: perioperative during minimal invasive surgery
description: cardial biomarker for myocardial damage
measure: Creatinkinase Muscle- Brain (CK-MB) (U/l)
time frame: perioperative during minimal invasive surgery
description: cardial biomarker for myocardial damage
measure: mortality rate
time frame: from minimal invasive surgery until 30 days post surgery
description: number of deaths
measure: length of stay in intensive care unit (days)
time frame: from minimal invasive surgery until 30 days post surgery
description: length of stay in intensive care unit (number of days)
arm group label: HTK-Bretschneider cardioplegic solution
description: Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution
arm group label: St. Thomas cardioplegic solution
description: Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution
intervention type: Other
intervention name: cardioplegia with HTK-Bretschneider cardioplegic solution
description: cardioplegia with HTK-Bretschneider cardioplegic solution
arm group label: HTK-Bretschneider cardioplegic solution
intervention type: Other
intervention name: cardioplegia with St. Thomas cardioplegic solution
description: cardioplegia with St. Thomas cardioplegic solution
arm group label: St. Thomas cardioplegic solution
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Martin Grapow, Prof. Dr.
role: Principal Investigator
affiliation: Klinik für Herzchirurgie, Universitätsspital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cardioplegic Solutions
mesh term: Pharmaceutical Solutions