<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/NCT03765814</url>
  </required_header>
  <id_info>
    <org_study_id>2018-CHITS-02</org_study_id>
    <secondary_id>2018-A01455-50</secondary_id>
    <nct_id>NCT03765814</nct_id>
  </id_info>
  <brief_title>The Anticipated Organ Donation Approach</brief_title>
  <acronym>PREMORENCE</acronym>
  <official_title>Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</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>
      The purpose of this study is to make a paramedical evaluation of a selection procedure of&#xD;
      serious brain-injured patient in therapeutic abstention to a brain death state within 48&#xD;
      hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2016 in France, 5891 organs have been transplanted. All the transplant's sources are&#xD;
      developed (brain death, Maastricht III, living organ donor).&#xD;
&#xD;
      However, the French Transplant's plan 2017-2021 require always more transplant, the aim is to&#xD;
      reach 7800 transplants in 4 years.&#xD;
&#xD;
      To increase the number of transplants, one of the strategies is to actively identify the&#xD;
      donors in brain death state and the donors with wider criteria. It's mainly serious&#xD;
      brain-injured patients.&#xD;
&#xD;
      The procedure of early announcement of organ donation consists in beginning or pursues&#xD;
      intensive care on serious brain-injured patient, for whom a decision of abstention of&#xD;
      therapeutic active was decided. The only purpose of the medical care is to notice the brain&#xD;
      death state that lead to donation.&#xD;
&#xD;
      In 2010, an expert group of the &quot;Société de reanimation de langue Française&quot; established&#xD;
      guidelines to manage organ's donation in serious brain-injured patient after a stroke. The&#xD;
      interest, to admit these serious brain-injured patients in intensive care unit, is to&#xD;
      increase the number of donors in state of brain death and so the number of transplants.&#xD;
&#xD;
      However the guidelines remain little practised and little known in France. The number of bed&#xD;
      in intensive care unit is limited and requires a selection of the potential organ donors. To&#xD;
      hospitalised serious brain-injured patients in intensive care unit, there are no validated&#xD;
      selection criteria that make difficult the implication of the transplant coordination in this&#xD;
      anticipated announcement's approach.&#xD;
&#xD;
      In Toulon hospital, a standardize selection procedure was initiated and applied&#xD;
      systematically by the transplant coordinator for each serious brain-injured patients. The&#xD;
      selected patients will evolve in brain death state in 48 hours and could be organ donors.&#xD;
&#xD;
      The aim of this study is to validate a paramedical procedure to increase the number of organ&#xD;
      donors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2019</start_date>
  <completion_date type="Anticipated">September 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2024</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>Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Ratio between the number of non-eligible patients and the total number of calls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Ratio between the number of family refusal and the total number of patients for whom the anticipated announcement procedure was started.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of refusal causes in the population</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Number of refusal causes will be presented globally</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the delay between eligibility validation and the passage in brain death state.</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>The passage delay between eligibility validation and brain death state is defined by the time in hours between the examination which validates patient's eligibility and the diagnosis of brain death state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the rate of patients with organ removal in enrolled patients.</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Ratio between the number of patient who performed organ donation and the total number of patients included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of organ harvested by patient.</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>Number of organs collected will be presented globally, by patient and by type of organ transplanted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of transplants performed.</measure>
    <time_frame>10 days</time_frame>
    <description>The number of transplants performed will be presented globally, by patient and by type of organs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient enrolled by type of service.</measure>
    <time_frame>48 hours after validation of eligibility</time_frame>
    <description>The number of patient enrolled in the intensive care unit, the Emergency or Neurovascular intensive care unit will be described globally</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non harvested organs which have been suggested for transplant</measure>
    <time_frame>10 days</time_frame>
    <description>The proportion of suggested non harvested organs will be determined as the number of suggested non harvested organs divided by the total number of non harvested organs. Reasons of suggested organs refusal will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state</measure>
    <time_frame>10 days</time_frame>
    <description>The rate of patients with Maastricht 3 organ donation will be determined as the number of patients having performed Maastricht 3 organ donation divided by the number of patients who didn't evolve to brain death state after 48hours</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Brain Death</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Seriously brain-injured patient with therapeutic abstention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female over 18 years-old&#xD;
&#xD;
          -  Patient with serious brain damages&#xD;
&#xD;
          -  Medical decision of withdrawing life sustaining treatment&#xD;
&#xD;
          -  Signed and dated informed consent by trusted person, or family&#xD;
&#xD;
          -  Patient covered by social security regimen&#xD;
&#xD;
          -  Patient eligible for organ donation according to organ donation hospital co-ordination&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) :&#xD;
&#xD;
               -  Seriously brain-injured patient without confounding factors, head trauma, brain&#xD;
                  anoxia or ischemic stroke : GCS&lt;5 and loss of bilateral corneal reflex or GCS&lt;5&#xD;
                  and loss of three brain stem reflexes&#xD;
&#xD;
               -  Seriously brain-injured patient with confounding factors and without head trauma,&#xD;
                  brain anoxia or ischemic stroke : at least one of the following scanographic sign&#xD;
                  of gravity : deletion of subarachnoid cisterns, more than 15 mm deviation of the&#xD;
                  median line, hematoma volume &gt; 65 cm3 or hydrocephalus due to intra-ventricular&#xD;
                  bleeding with V3 or V4 flood, and, if documented, a GCS&lt;7.&#xD;
&#xD;
               -  Patient with head trauma, brain anoxia or ischemic stroke, reliable clinical&#xD;
                  examination required (no confounding factor) : GCS&lt;5 and loss of bilateral&#xD;
                  corneal reflex or GCS&lt;5 and loss of three brain stem reflexes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No trusted person or family present&#xD;
&#xD;
          -  Seriously brain-injured patient because of head trauma, brain anoxia or ischemic&#xD;
             stroke with confounding factors&#xD;
&#xD;
          -  Absolute contraindication to organ donation known at the moment of inclusion (HIV,&#xD;
             rabies, active cancer, active tuberculosis, Creutzfeldt-Jakob disease)&#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>Valérie Arsonneau</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Intercommunal Toulon La Seyne sur Mer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asmaa Jobic</last_name>
    <phone>04.83.77.20.61</phone>
    <phone_ext>+33</phone_ext>
    <email>asmaa.jobic@ch-toulon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <state>Haute Savoie</state>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Lebouc</last_name>
      <phone>0450637133</phone>
      <phone_ext>+33</phone_ext>
      <email>mlebouc@ch-annecygenevois.fr</email>
    </contact>
    <investigator>
      <last_name>Didier Dorez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <state>Loire-Atlantique</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Laurence Saulnier, Nurse</last_name>
      <phone>02 53 48 22 45</phone>
      <phone_ext>+33</phone_ext>
      <email>marielaurence.saulnier@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent Martin-Lefevre, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal Toulon La Seyne sur Mer</name>
      <address>
        <city>Toulon</city>
        <state>Var</state>
        <zip>83200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Blaisine Bayard, Nurse</last_name>
      <phone>0494145063</phone>
      <phone_ext>+33</phone_ext>
      <email>blaisine.bayard@ch-toulon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental de Vendée Les Oudairies</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <state>Vendée</state>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natacha Maquigneau, Nurse</last_name>
      <phone>0251446026</phone>
      <phone_ext>+33</phone_ext>
      <email>natacha.maquigneau@ght85.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent Martin-Lefèvre, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>organ donation</keyword>
  <keyword>serious brain-injured patient</keyword>
  <keyword>anticipated approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Death</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan</ipd_description>
  </patient_data>
  <!-- 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/NCT03765814
org study id: 2018-CHITS-02
secondary id: 2018-A01455-50
nct id: NCT03765814
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to make a paramedical evaluation of a selection procedure of
      serious brain-injured patient in therapeutic abstention to a brain death state within 48
      hours.
In 2016 in France, 5891 organs have been transplanted. All the transplant's sources are
      developed (brain death, Maastricht III, living organ donor).

      However, the French Transplant's plan 2017-2021 require always more transplant, the aim is to
      reach 7800 transplants in 4 years.

      To increase the number of transplants, one of the strategies is to actively identify the
      donors in brain death state and the donors with wider criteria. It's mainly serious
      brain-injured patients.

      The procedure of early announcement of organ donation consists in beginning or pursues
      intensive care on serious brain-injured patient, for whom a decision of abstention of
      therapeutic active was decided. The only purpose of the medical care is to notice the brain
      death state that lead to donation.

      In 2010, an expert group of the "Société de reanimation de langue Française" established
      guidelines to manage organ's donation in serious brain-injured patient after a stroke. The
      interest, to admit these serious brain-injured patients in intensive care unit, is to
      increase the number of donors in state of brain death and so the number of transplants.

      However the guidelines remain little practised and little known in France. The number of bed
      in intensive care unit is limited and requires a selection of the potential organ donors. To
      hospitalised serious brain-injured patients in intensive care unit, there are no validated
      selection criteria that make difficult the implication of the transplant coordination in this
      anticipated announcement's approach.

      In Toulon hospital, a standardize selection procedure was initiated and applied
      systematically by the transplant coordinator for each serious brain-injured patients. The
      selected patients will evolve in brain death state in 48 hours and could be organ donors.

      The aim of this study is to validate a paramedical procedure to increase the number of organ
      donors.
observational model: Cohort
time perspective: Prospective
measure: Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.
time frame: 48 hours after validation of eligibility
description: Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility
measure: Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement
time frame: 48 hours after validation of eligibility
description: Ratio between the number of non-eligible patients and the total number of calls
measure: Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit
time frame: 48 hours after validation of eligibility
description: Ratio between the number of family refusal and the total number of patients for whom the anticipated announcement procedure was started.
measure: Number of refusal causes in the population
time frame: 48 hours after validation of eligibility
description: Number of refusal causes will be presented globally
measure: Evaluation of the delay between eligibility validation and the passage in brain death state.
time frame: 48 hours after validation of eligibility
description: The passage delay between eligibility validation and brain death state is defined by the time in hours between the examination which validates patient's eligibility and the diagnosis of brain death state.
measure: Evaluation of the rate of patients with organ removal in enrolled patients.
time frame: 48 hours after validation of eligibility
description: Ratio between the number of patient who performed organ donation and the total number of patients included.
measure: Number and type of organ harvested by patient.
time frame: 48 hours after validation of eligibility
description: Number of organs collected will be presented globally, by patient and by type of organ transplanted.
measure: Number of transplants performed.
time frame: 10 days
description: The number of transplants performed will be presented globally, by patient and by type of organs.
measure: Number of patient enrolled by type of service.
time frame: 48 hours after validation of eligibility
description: The number of patient enrolled in the intensive care unit, the Emergency or Neurovascular intensive care unit will be described globally
measure: Non harvested organs which have been suggested for transplant
time frame: 10 days
description: The proportion of suggested non harvested organs will be determined as the number of suggested non harvested organs divided by the total number of non harvested organs. Reasons of suggested organs refusal will be presented.
measure: Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state
time frame: 10 days
description: The rate of patients with Maastricht 3 organ donation will be determined as the number of patients having performed Maastricht 3 organ donation divided by the number of patients who didn't evolve to brain death state after 48hours
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valérie Arsonneau
role: Study Director
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
last name: Asmaa Jobic
phone: 04.83.77.20.61
phone ext: +33
email: asmaa.jobic@ch-toulon.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Brain Death
mesh term: Death
sharing ipd: No
ipd description: no plan