xml: <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/NCT06032195</url>
    </required_header>
    <id_info>
      <org_study_id>CL-N-HTX-Paed-II/10/20</org_study_id>
      <nct_id>NCT06032195</nct_id>
    </id_info>
    <brief_title>Study of Organ Perfusion in Heart Transplantation in Children</brief_title>
    <official_title>A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. F. Köhler Chemie GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr. F. Köhler Chemie GmbH</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this prospective randomized single blind multicenter phase II study is to compare&#xD;
        organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all&#xD;
        ages (birth to &lt;18 years) being listed on the waiting list for heart transplantation. The&#xD;
        main question it aims to answer is:&#xD;
  &#xD;
        to compare the safety of Custodiol-N in heart transplantation in children in comparison to&#xD;
        its precursor product Custodiol.&#xD;
  &#xD;
        Participants will receive either a heart to be transplanted, either perfused with Custodiol-N&#xD;
        or Custodiol to Researchers will compare the two solutions to see if the new solution&#xD;
        Custodiol-N is safe in heart transplantation in children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in&#xD;
        patients with end stage heart failure when other treatments have failed.&#xD;
  &#xD;
        The surgical procedures for orthotopic heart transplantation are essentially the same in&#xD;
        adult and paediatric patients . Due to anatomical variants in congenital heart disease the&#xD;
        procurement procedure may be modified with regard to the extent of the Vena cava superior and&#xD;
        the great vessels. In implantation most frequently the bicaval technique is used but the&#xD;
        biatrial technique which is leaving the back wall of both atria in situ may also be employed.&#xD;
  &#xD;
        A main difference between adult and paediatric heart transplantation (HTx) are the&#xD;
        indications for transplantation: In adults the majority of patients undergo HTx as treatment&#xD;
        of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other&#xD;
        treatments have failed. Infants younger than one year of age congenital heart disease (CHD)&#xD;
        is the most common diagnosis representing more than every second case followed by dilated&#xD;
        cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most&#xD;
        frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery&#xD;
        and in whom myocardial dysfunction develops later .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>adverse event reporting</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Safety assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>heart rate</measure>
      <time_frame>up to day 7 after release of the aortic cross clamp</time_frame>
      <description>vital parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood pressure (systolic (SBP) and diastolic (DBP))</measure>
      <time_frame>up to day 7 after release of the aortic cross clamp</time_frame>
      <description>vital parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>body temperature</measure>
      <time_frame>up to day 7 after release of the aortic cross clamp</time_frame>
      <description>vital parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>concentration of cardiac troponin</measure>
      <time_frame>up to day 7 after release of the aortic cross clamp</time_frame>
      <description>laboratory tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>concentration of creatinine kinase (CK-MB)</measure>
      <time_frame>up to day 7 after release of the aortic cross clamp</time_frame>
      <description>laboratory tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(SBP (systolic blood pressure), DBP (diastolic blood pressure))</measure>
      <time_frame>from termination of cardiopulmonary bypass until transfer to intensive care unit</time_frame>
      <description>Haemodynamics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rhythm (HR)</measure>
      <time_frame>from termination of cardiopulmonary bypass until transfer to intensive care unit</time_frame>
      <description>Haemodynamics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary artery pressure (PAP (if available))</measure>
      <time_frame>from termination of cardiopulmonary bypass until transfer to intensive care unit</time_frame>
      <description>Haemodynamics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cerebrovascular resistance (CVR (if available))</measure>
      <time_frame>from termination of cardiopulmonary bypass until transfer to intensive care unit</time_frame>
      <description>Haemodynamics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death</measure>
      <time_frame>up to 12 months</time_frame>
      <description>survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>function of transplanted organ (heart)</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Graft survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission to intensive care unit (ICU)</measure>
      <time_frame>up to 3 months</time_frame>
      <description>return to intensive care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of ICU stays</measure>
      <time_frame>up to 3 months</time_frame>
      <description>duration of stay in intensive care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Catecholamine requirement</measure>
      <time_frame>up to day 7</time_frame>
      <description>(yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antihypertensives intake</measure>
      <time_frame>up to 12 months</time_frame>
      <description>(yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Milrinone support</measure>
      <time_frame>up to day 7</time_frame>
      <description>(yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for pacemaker therapy</measure>
      <time_frame>up to day 7</time_frame>
      <description>(yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Left and right ventricular assist device (LVAD, RVAD)</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Device therapy (each yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Extracorporeal membrane oxygenation (ECMO)</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Device therapy (each yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biventricular assist Device (BIVAD) or percutaneous LVAD</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Device therapy (each yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ejection fraction</measure>
      <time_frame>up to day 7</time_frame>
      <description>Echocardiographic markers of function and rejection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>enddiastolic and endsystolic ventricle</measure>
      <time_frame>up to day 7</time_frame>
      <description>Echocardiographic markers of function and rejection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac arrhythmias</measure>
      <time_frame>up to day 7</time_frame>
      <description>occurrence, severity, type</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Heart Transplantation</condition>
    <arm_group>
      <arm_group_label>Custodiol-N</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>organ will be perfused with Custodiol-N solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Custodiol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>organ will be perfused with Custodiol solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Custodiol-N</intervention_name>
      <description>heart will preserved in and will be treated with Custodiol-N solution</description>
      <arm_group_label>Custodiol-N</arm_group_label>
      <other_name>Solution for organ preservation in transplantation</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Custodiol</intervention_name>
      <description>heart will preserved in and will be treated with Custodiol solution</description>
      <arm_group_label>Custodiol</arm_group_label>
      <other_name>Solution for organ preservation in transplantation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age from birth to less than18 years&#xD;
  &#xD;
            -  Recipients awaiting their first transplant&#xD;
  &#xD;
            -  Ability of the patients and/ or their legal guardians to understand character and&#xD;
               individual consequences of the clinical trial&#xD;
  &#xD;
            -  written informed consent of the patients and/ or their legal guardians (must be&#xD;
               available before enrolment in the study)&#xD;
  &#xD;
            -  Patient listed on the waiting list for heart transplantation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have participated within 30 days or are still participating in any other&#xD;
               interventional studies&#xD;
  &#xD;
            -  history of severe organic disease other than concerning the heart&#xD;
  &#xD;
            -  history/demonstration of HIV antibodies or AIDS&#xD;
  &#xD;
            -  multiorgan transplantation&#xD;
  &#xD;
            -  machine-perfused organ&#xD;
  &#xD;
            -  the explantation team is affiliated to another clinic than transplantation team&#xD;
  &#xD;
            -  Failing Fontan patients&#xD;
  &#xD;
            -  Patients who have been incarcerated or involuntarily institutionalized by court order&#xD;
               or by the authorities&#xD;
  &#xD;
            -  Pregnancy and lactation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>24 Hours</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christoph Knosalla, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>German Heart Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Deutsches Herzzentrum der Charité</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie</name>
        <address>
          <city>Gießen</city>
          <zip>35385</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik</name>
        <address>
          <city>München</city>
          <zip>81377</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharmaceutical Solutions</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032195
  org study id: CL-N-HTX-Paed-II/10/20
  nct id: NCT06032195
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective randomized single blind multicenter phase II study is to compare
        organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all
        ages (birth to <18 years) being listed on the waiting list for heart transplantation. The
        main question it aims to answer is:
  
        to compare the safety of Custodiol-N in heart transplantation in children in comparison to
        its precursor product Custodiol.
  
        Participants will receive either a heart to be transplanted, either perfused with Custodiol-N
        or Custodiol to Researchers will compare the two solutions to see if the new solution
        Custodiol-N is safe in heart transplantation in children.
  Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in
        patients with end stage heart failure when other treatments have failed.
  
        The surgical procedures for orthotopic heart transplantation are essentially the same in
        adult and paediatric patients . Due to anatomical variants in congenital heart disease the
        procurement procedure may be modified with regard to the extent of the Vena cava superior and
        the great vessels. In implantation most frequently the bicaval technique is used but the
        biatrial technique which is leaving the back wall of both atria in situ may also be employed.
  
        A main difference between adult and paediatric heart transplantation (HTx) are the
        indications for transplantation: In adults the majority of patients undergo HTx as treatment
        of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other
        treatments have failed. Infants younger than one year of age congenital heart disease (CHD)
        is the most common diagnosis representing more than every second case followed by dilated
        cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most
        frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery
        and in whom myocardial dysfunction develops later .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
  measure: adverse event reporting
  time frame: up to 3 months
  description: Safety assessment
  measure: heart rate
  time frame: up to day 7 after release of the aortic cross clamp
  description: vital parameters
  measure: blood pressure (systolic (SBP) and diastolic (DBP))
  time frame: up to day 7 after release of the aortic cross clamp
  description: vital parameters
  measure: body temperature
  time frame: up to day 7 after release of the aortic cross clamp
  description: vital parameters
  measure: concentration of cardiac troponin
  time frame: up to day 7 after release of the aortic cross clamp
  description: laboratory tests
  measure: concentration of creatinine kinase (CK-MB)
  time frame: up to day 7 after release of the aortic cross clamp
  description: laboratory tests
  measure: (SBP (systolic blood pressure), DBP (diastolic blood pressure))
  time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
  description: Haemodynamics
  measure: Heart Rhythm (HR)
  time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
  description: Haemodynamics
  measure: Pulmonary artery pressure (PAP (if available))
  time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
  description: Haemodynamics
  measure: Cerebrovascular resistance (CVR (if available))
  time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
  description: Haemodynamics
  measure: Death
  time frame: up to 12 months
  description: survival
  measure: function of transplanted organ (heart)
  time frame: up to 3 months
  description: Graft survival
  measure: Readmission to intensive care unit (ICU)
  time frame: up to 3 months
  description: return to intensive care unit
  measure: Length of ICU stays
  time frame: up to 3 months
  description: duration of stay in intensive care unit
  measure: Catecholamine requirement
  time frame: up to day 7
  description: (yes/no)
  measure: Antihypertensives intake
  time frame: up to 12 months
  description: (yes/no)
  measure: Milrinone support
  time frame: up to day 7
  description: (yes/no)
  measure: Need for pacemaker therapy
  time frame: up to day 7
  description: (yes/no)
  measure: Left and right ventricular assist device (LVAD, RVAD)
  time frame: up to 3 months
  description: Device therapy (each yes/no)
  measure: Extracorporeal membrane oxygenation (ECMO)
  time frame: up to 3 months
  description: Device therapy (each yes/no)
  measure: Biventricular assist Device (BIVAD) or percutaneous LVAD
  time frame: up to 3 months
  description: Device therapy (each yes/no)
  measure: Ejection fraction
  time frame: up to day 7
  description: Echocardiographic markers of function and rejection
  measure: enddiastolic and endsystolic ventricle
  time frame: up to day 7
  description: Echocardiographic markers of function and rejection
  measure: Cardiac arrhythmias
  time frame: up to day 7
  description: occurrence, severity, type
  arm group label: Custodiol-N
  arm group type: Experimental
  description: organ will be perfused with Custodiol-N solution
  arm group label: Custodiol
  arm group type: Active Comparator
  description: organ will be perfused with Custodiol solution
  intervention type: Drug
  intervention name: Custodiol-N
  description: heart will preserved in and will be treated with Custodiol-N solution
  arm group label: Custodiol-N
  other name: Solution for organ preservation in transplantation
  intervention type: Drug
  intervention name: Custodiol
  description: heart will preserved in and will be treated with Custodiol solution
  arm group label: Custodiol
  other name: Solution for organ preservation in transplantation
  criteria: 
  gender: All
  minimum age: 24 Hours
  maximum age: 17 Years
  healthy volunteers: No
  last name: Christoph Knosalla, Prof. Dr.
  role: Principal Investigator
  affiliation: German Heart Institute
  facility: 
  facility: 
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Pharmaceutical Solutions
  sharing ipd: No