<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/NCT03823521</url>
  </required_header>
  <id_info>
    <org_study_id>SCT-Cpx-004</org_study_id>
    <nct_id>NCT03823521</nct_id>
  </id_info>
  <brief_title>Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™</brief_title>
  <official_title>A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Cardio Technologies AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Cardio Technologies AG</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>
      This is a multi-center, open label, single group, observational study designed to evaluate&#xD;
      the effects of a Cardioplexol™ preparation and administration training program proposed to&#xD;
      cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.&#xD;
&#xD;
      The training program aims at increasing the efficacy of Cardioplexol administration while&#xD;
      reducing the risk of false manipulations. During the training possible risks and consequences&#xD;
      of incorrect applications as well as the measures to take in case of administration error,&#xD;
      are discussed. The training program includes one standardized theoretical part and one&#xD;
      practical part consisting of a direct intra-operative coaching of surgeons practicing their&#xD;
      first 2 operations.&#xD;
&#xD;
      The effect of the training will then be assessed by evaluating each trained surgeon's 4 next&#xD;
      consecutive patients operated with Cardioplexol and without the coach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">October 18, 2021</completion_date>
  <primary_completion_date type="Actual">October 18, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major Deviation in Cardioplexol application</measure>
    <time_frame>During surgery</time_frame>
    <description>Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TnT Values</measure>
    <time_frame>During the first 24 hours following myocardial reperfusion</time_frame>
    <description>Development of concentration of blood Troponin T values measured by the local hospital laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CK-MB Values</measure>
    <time_frame>During the first 24 hours following myocardial reperfusion</time_frame>
    <description>Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Cardiac Arrest</measure>
    <time_frame>During Surgery</time_frame>
    <description>Time between the aortic cross-clamping and the complete cardiac arrest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catecholamine</measure>
    <time_frame>During during aortic cross-clamping and during the first 24 hours</time_frame>
    <description>Cumulative dose of catecholamines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Defibrillation rate</measure>
    <time_frame>During surgery</time_frame>
    <description>Defibrillation rate after aorta unclamping and coronary reperfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>During follow-up phase after surgery up to 35 days</time_frame>
    <description>Duration of ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>During the first 24 hours following coronary reperfusion</time_frame>
    <description>Number of patients, who died</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Coronary Artery Bypass Surgery</condition>
  <condition>Valve Surgery</condition>
  <arm_group>
    <arm_group_label>Cardioplexol™- Cardioplegia Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cardioplexol™ will be used as cardioplegic solution in cardiac surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cardioplegia Solution</intervention_name>
    <description>Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution</description>
    <arm_group_label>Cardioplexol™- Cardioplegia Solution</arm_group_label>
    <other_name>Cardioplexol™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients between 18 and 80 years of age;&#xD;
&#xD;
          -  The patient's pre-operative evaluation indicates the need for a primary elective&#xD;
             cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve&#xD;
             repair/replacement;&#xD;
&#xD;
          -  The operation can be carried out via a full sternotomy, under cardiac arrest and under&#xD;
             the assistance of a heart lung machine;&#xD;
&#xD;
          -  Patients who provide signed written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-operative EF of less than 30%;&#xD;
&#xD;
          -  Pre-operative IABP;&#xD;
&#xD;
          -  Pre-operative catecholamine support;&#xD;
&#xD;
          -  History of myocardial infarction within less than 7 days;&#xD;
&#xD;
          -  Previous history of cardiac surgery, including the implantation of a pace maker or an&#xD;
             ICD;&#xD;
&#xD;
          -  Active myocarditis and/or endocarditis;&#xD;
&#xD;
          -  Aortic valve insufficiency severity grade more than 1;&#xD;
&#xD;
          -  Under dialysis;&#xD;
&#xD;
          -  Pre-operative serum creatinine value of more than 2.0 mg/dl;&#xD;
&#xD;
          -  Known hematologic disorder;&#xD;
&#xD;
          -  Treatment with anti-vitamin K;&#xD;
&#xD;
          -  History of HIT;&#xD;
&#xD;
          -  Participating in a concomitant research study of an investigational product;&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to&#xD;
             give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinik Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklnikum St. Pölten</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Hietzing</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardioplegic Solutions</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardioplegic 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/NCT03823521
org study id: SCT-Cpx-004
nct id: NCT03823521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center, open label, single group, observational study designed to evaluate
      the effects of a Cardioplexol™ preparation and administration training program proposed to
      cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.

      The training program aims at increasing the efficacy of Cardioplexol administration while
      reducing the risk of false manipulations. During the training possible risks and consequences
      of incorrect applications as well as the measures to take in case of administration error,
      are discussed. The training program includes one standardized theoretical part and one
      practical part consisting of a direct intra-operative coaching of surgeons practicing their
      first 2 operations.

      The effect of the training will then be assessed by evaluating each trained surgeon's 4 next
      consecutive patients operated with Cardioplexol and without the coach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Major Deviation in Cardioplexol application
time frame: During surgery
description: Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).
measure: TnT Values
time frame: During the first 24 hours following myocardial reperfusion
description: Development of concentration of blood Troponin T values measured by the local hospital laboratory
measure: CK-MB Values
time frame: During the first 24 hours following myocardial reperfusion
description: Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory
measure: Complete Cardiac Arrest
time frame: During Surgery
description: Time between the aortic cross-clamping and the complete cardiac arrest
measure: Catecholamine
time frame: During during aortic cross-clamping and during the first 24 hours
description: Cumulative dose of catecholamines
measure: Defibrillation rate
time frame: During surgery
description: Defibrillation rate after aorta unclamping and coronary reperfusion.
measure: ICU stay
time frame: During follow-up phase after surgery up to 35 days
description: Duration of ICU stay
measure: Mortality
time frame: During the first 24 hours following coronary reperfusion
description: Number of patients, who died
arm group label: Cardioplexol™- Cardioplegia Solution
arm group type: Experimental
description: Cardioplexol™ will be used as cardioplegic solution in cardiac surgery
intervention type: Drug
intervention name: Cardioplegia Solution
description: Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
arm group label: Cardioplexol™- Cardioplegia Solution
other name: Cardioplexol™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Cardioplegic Solutions