<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/NCT01662375</url>
  </required_header>
  <id_info>
    <org_study_id>RC12_0038</org_study_id>
    <nct_id>NCT01662375</nct_id>
  </id_info>
  <brief_title>A Prospective Study Evaluating the Feasibility and Ethical Perspective of Maastricht III Organ Procurement in French Intensive Care Unit Patients</brief_title>
  <acronym>MIII</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Maastricht III procedure consists of performing organ donation in patients in whom&#xD;
      cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is&#xD;
      not applied in France, in contrast with other industrialized countries.The proposed study is&#xD;
      designed to evaluate the feasibility of adapting the MIII procedure in France by conducting a&#xD;
      single-centre, prospective study. Within the population of patients admitted to the Nantes&#xD;
      University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to&#xD;
      withdraw life support, the investigators want to determine the delay elapsed between the life&#xD;
      support withdrawing and the onset of spontaneous cardiac arrest, that is without any&#xD;
      intentional procedure susceptible of precipitate the death onset. The cardiovascular state&#xD;
      observed during this period and its duration determine the viability of the organs harvested.&#xD;
      The invetigators also want to determine the incidence of refusal of organ donation that would&#xD;
      be formulated by the family and/or loved ones if they had been asked to consent to an MIII&#xD;
      procedure at the time of announcement of the clinical team's decision to withdraw life&#xD;
      support.Anonymous data concerning the patient will be collected by using a predefined grid,&#xD;
      completed partly by the medical team in charge of the patient and partly by a CRA from data&#xD;
      in the patient's medical file.The study with families and/or loved ones will be conducted in&#xD;
      the context of the CHU de NANTES Clinical Ethics Unit and according to this unit's&#xD;
      methodology. The main working tool used by the Clinical Ethics Unit consists of interviews&#xD;
      between its members and the various parties participating in elaboration of a decision (in&#xD;
      this case, the virtual possibility of organ donation according to the MIII procedure).The&#xD;
      purpose of this interview is to stimulate reflection on issues not previously considered, by&#xD;
      introducing new elements and by using, as a tool, the principles of biomedical ethics&#xD;
      developed by Beauchamps and Childress. This study should be able to determine which types of&#xD;
      patients could be concerned by the Maastricht III procedure. The expected results should help&#xD;
      to define the quantitative impact and feasibility of this procedure on organ donation and&#xD;
      could be used to subsequently propose a larger-scale multicenter prospective study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Delay between the withdrawal of intensive care and spontaneous cardiac arrest</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Intensive Care</condition>
  <condition>Supportive Care</condition>
  <condition>Withdrawal of Life Support</condition>
  <arm_group>
    <arm_group_label>MIII</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surveillance and interview</intervention_name>
    <description>The interventional nature of the study is justified by the need for particular monitoring of patients in whom life support is withdrawn following the clinical team's decision. The questions posed to the patient's family and/or relatives, do not modify the care provided to the patient.</description>
    <arm_group_label>MIII</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        These are patients medical or surgical intensive care who are subject to a collective&#xD;
        decision to stop intensive care treatments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients eligible to life support withdrawing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>October 20, 2014</last_update_submitted>
  <last_update_submitted_qc>October 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01662375
org study id: RC12_0038
nct id: NCT01662375
lead sponsor: 
has dmc: No
The Maastricht III procedure consists of performing organ donation in patients in whom
      cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is
      not applied in France, in contrast with other industrialized countries.The proposed study is
      designed to evaluate the feasibility of adapting the MIII procedure in France by conducting a
      single-centre, prospective study. Within the population of patients admitted to the Nantes
      University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to
      withdraw life support, the investigators want to determine the delay elapsed between the life
      support withdrawing and the onset of spontaneous cardiac arrest, that is without any
      intentional procedure susceptible of precipitate the death onset. The cardiovascular state
      observed during this period and its duration determine the viability of the organs harvested.
      The invetigators also want to determine the incidence of refusal of organ donation that would
      be formulated by the family and/or loved ones if they had been asked to consent to an MIII
      procedure at the time of announcement of the clinical team's decision to withdraw life
      support.Anonymous data concerning the patient will be collected by using a predefined grid,
      completed partly by the medical team in charge of the patient and partly by a CRA from data
      in the patient's medical file.The study with families and/or loved ones will be conducted in
      the context of the CHU de NANTES Clinical Ethics Unit and according to this unit's
      methodology. The main working tool used by the Clinical Ethics Unit consists of interviews
      between its members and the various parties participating in elaboration of a decision (in
      this case, the virtual possibility of organ donation according to the MIII procedure).The
      purpose of this interview is to stimulate reflection on issues not previously considered, by
      introducing new elements and by using, as a tool, the principles of biomedical ethics
      developed by Beauchamps and Childress. This study should be able to determine which types of
      patients could be concerned by the Maastricht III procedure. The expected results should help
      to define the quantitative impact and feasibility of this procedure on organ donation and
      could be used to subsequently propose a larger-scale multicenter prospective study.
observational model: Family-Based
time perspective: Prospective
measure: Delay between the withdrawal of intensive care and spontaneous cardiac arrest
time frame: 1 day
arm group label: MIII
intervention type: Other
intervention name: Surveillance and interview
description: The interventional nature of the study is justified by the need for particular monitoring of patients in whom life support is withdrawn following the clinical team's decision. The questions posed to the patient's family and/or relatives, do not modify the care provided to the patient.
arm group label: MIII
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor