<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/NCT04408495</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_8854_VACARM</org_study_id>
    <nct_id>NCT04408495</nct_id>
  </id_info>
  <brief_title>Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients</brief_title>
  <acronym>VACARM</acronym>
  <official_title>Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Controversies remain concerning the best intraoperative mechanical ventilation regimen for&#xD;
      major cardiac surgery. While the use of intra operative low tidal volumes is now standard&#xD;
      practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of&#xD;
      recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two&#xD;
      regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac&#xD;
      surgery patients at risk of postoperative pulmonary complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized controlled trial, cardiac surgery patients at risk of postoperative&#xD;
      pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM&#xD;
      or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint&#xD;
      will be a composite endpoint including major postoperative complications within the first&#xD;
      postoperative week and death within the 28 days after surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2021</start_date>
  <completion_date type="Anticipated">July 8, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 8, 2025</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Multicenter, randomized, comparative, parallel-group trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of major pulmonary complications and death</measure>
    <time_frame>28 days after surgery</time_frame>
    <description>Major pulmonary complications, defined as prolonged mechanical ventilation &gt;24h post-operatively, pneumonia (defined according to the 2017 French guidelines) or reintubation for any cause within 7 post-operative days, or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with hypotension</measure>
    <time_frame>intraoperative period</time_frame>
    <description>Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>30 minutes after extubation</time_frame>
    <description>Measure of PaO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>30 minutes after extubation</time_frame>
    <description>Measure of HCO3 (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>30 minutes after extubation</time_frame>
    <description>Measure of PaCO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>30 minutes after extubation</time_frame>
    <description>Measure of SaO2 (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure of PaO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure of HCO3 (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure of PaCO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure of SaO2 (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 2</time_frame>
    <description>Measure of PaO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 2</time_frame>
    <description>Measure of HCO3 (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 2</time_frame>
    <description>Measure of PaCO2 (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the postoperative blood gases</measure>
    <time_frame>Day 2</time_frame>
    <description>Measure of SaO2 (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>Day 0</time_frame>
    <description>Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>Day 3</time_frame>
    <description>Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>Day 5</time_frame>
    <description>Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily evaluation of organ failure</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>SOFA score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily evaluation of delirium</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>CAM-ICU scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Postoperative pulmonary complications (PPC)</measure>
    <time_frame>within the 28 days after surgery</time_frame>
    <description>Pneumonia (defined according to the 2017 French guidelines), re-intubation within 7 days, mechanical ventilation &gt;24h, pneumothorax, Atelectasis, Acute Respiratory Distress Syndrome. PPC grade (according to Huzelbos et al; JAMA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Postoperative non pulmonary complications</measure>
    <time_frame>within the 28 days after surgery</time_frame>
    <description>Re intervention for acute bleeding, Pericardial Tamponade, Sternal wound infection, Ventricular Arrhythmia, Atrial fibrillation, Myocardial infarction, Mesenteric ischemia, Sepsis/septic shock, Acute kidney injury with renal replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation duration, length of stay in ICU and in the study hospital and death</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of Ventilatory-free days, vasopressor-free days, ICU-free days and hospital-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of systemic inflammation and of epithelial and endothelial aggression</measure>
    <time_frame>Day 0</time_frame>
    <description>Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of systemic inflammation and of epithelial and endothelial aggression</measure>
    <time_frame>Day 1</time_frame>
    <description>Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Postoperative Pulmonary Complications</condition>
  <arm_group>
    <arm_group_label>Intervention group_MRA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recruitment maneuvers and high PEEP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No recruitment maneuvers and low PEEP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intervention group_MRA</intervention_name>
    <description>Tidal Volume (Vt) =6-8 mL/kg of predicted body weight (PBW), Peep=8 cmH2O, recruitment maneuvers=30cm H2O every 30 min after intubation (except during CPB), after any disconnection and at the admission in ICU.&#xD;
Recruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg.&#xD;
Ventilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O</description>
    <arm_group_label>Intervention group_MRA</arm_group_label>
    <other_name>recruitment maneuvers</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Vt=6-8 mL/kg of PBW, Peep=5 cmH2O , No recruitment maneuvers. Ventilation maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>NO recruitment maneuvers</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years-old,&#xD;
&#xD;
          -  Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g.&#xD;
             coronary artery bypass grafting, valve, aorta, or combined procedures),&#xD;
&#xD;
          -  With a pulmonary risk score ≥ 2&#xD;
&#xD;
          -  Who gave written informed consent&#xD;
&#xD;
          -  affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 40kg/m2 ;&#xD;
&#xD;
          -  Left Ventricular Ejection Fraction &lt; 35% ;&#xD;
&#xD;
          -  Preoperative shock ;&#xD;
&#xD;
          -  Aortic surgery with planned circulatory arrest ;&#xD;
&#xD;
          -  Minimally invasive cardiac surgery ;&#xD;
&#xD;
          -  Emergency surgery with patient unable to give written informed consent&#xD;
&#xD;
          -  Heart transplantation&#xD;
&#xD;
          -  Mechanical circulatory support surgery&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Adults legally protected (under judicial protection, guardianship, or supervision),&#xD;
             persons deprived of their liberty&#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>Nathalie DEMAURE</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas NESSELER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Ferréol OILLEAU, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Brest</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanuelle LONGEAU, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertrand ROZEC, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas KERFONE, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Poitiers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabien ESPITALIER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Tours</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osama ABOU ARAB, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens-Picardie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathalie DEMAURE</last_name>
    <phone>299284321</phone>
    <email>nathalie.demaure@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicolas NESSELER, Dr</last_name>
    <email>nicolas.nesseler@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Amiens-Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Osama ABOU ARAB, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Ferréol OILLEAU, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thomas KERFONE, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathalie DEMAURE</last_name>
    </contact>
    <investigator>
      <last_name>Nicolas NESSELER, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathalie DEMAURE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Saint-Herblain</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bertrand ROZEC, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabien ESPITALIER, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recruitment maneuvers</keyword>
  <keyword>Postoperative pulmonary complications</keyword>
  <keyword>Peep</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Mortality</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04408495
org study id: 35RC18_8854_VACARM
nct id: NCT04408495
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Controversies remain concerning the best intraoperative mechanical ventilation regimen for
      major cardiac surgery. While the use of intra operative low tidal volumes is now standard
      practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of
      recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two
      regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac
      surgery patients at risk of postoperative pulmonary complications
In this randomized controlled trial, cardiac surgery patients at risk of postoperative
      pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM
      or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint
      will be a composite endpoint including major postoperative complications within the first
      postoperative week and death within the 28 days after surgery
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, randomized, comparative, parallel-group trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of major pulmonary complications and death
time frame: 28 days after surgery
description: Major pulmonary complications, defined as prolonged mechanical ventilation >24h post-operatively, pneumonia (defined according to the 2017 French guidelines) or reintubation for any cause within 7 post-operative days, or death
measure: Rate of patients with hypotension
time frame: intraoperative period
description: Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers
measure: Evaluate the postoperative blood gases
time frame: 30 minutes after extubation
description: Measure of PaO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: 30 minutes after extubation
description: Measure of HCO3 (mmol/l)
measure: Evaluate the postoperative blood gases
time frame: 30 minutes after extubation
description: Measure of PaCO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: 30 minutes after extubation
description: Measure of SaO2 (%)
measure: Evaluate the postoperative blood gases
time frame: Day 1
description: Measure of PaO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: Day 1
description: Measure of HCO3 (mmol/l)
measure: Evaluate the postoperative blood gases
time frame: Day 1
description: Measure of PaCO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: Day 1
description: Measure of SaO2 (%)
measure: Evaluate the postoperative blood gases
time frame: Day 2
description: Measure of PaO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: Day 2
description: Measure of HCO3 (mmol/l)
measure: Evaluate the postoperative blood gases
time frame: Day 2
description: Measure of PaCO2 (mmHg)
measure: Evaluate the postoperative blood gases
time frame: Day 2
description: Measure of SaO2 (%)
measure: Pulmonary function tests
time frame: Day 0
description: Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
measure: Pulmonary function tests
time frame: Day 3
description: Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
measure: Pulmonary function tests
time frame: Day 5
description: Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
measure: Daily evaluation of organ failure
time frame: Up to 7 days
description: SOFA score
measure: Daily evaluation of delirium
time frame: Up to 7 days
description: CAM-ICU scale
measure: Rate of Postoperative pulmonary complications (PPC)
time frame: within the 28 days after surgery
description: Pneumonia (defined according to the 2017 French guidelines), re-intubation within 7 days, mechanical ventilation >24h, pneumothorax, Atelectasis, Acute Respiratory Distress Syndrome. PPC grade (according to Huzelbos et al; JAMA)
measure: Rate of Postoperative non pulmonary complications
time frame: within the 28 days after surgery
description: Re intervention for acute bleeding, Pericardial Tamponade, Sternal wound infection, Ventricular Arrhythmia, Atrial fibrillation, Myocardial infarction, Mesenteric ischemia, Sepsis/septic shock, Acute kidney injury with renal replacement
measure: Ventilation duration, length of stay in ICU and in the study hospital and death
time frame: Day 28
description: Number of Ventilatory-free days, vasopressor-free days, ICU-free days and hospital-free days
measure: Mortality rate
time frame: Day 28
measure: Mortality rate
time frame: Day 90
measure: Mortality rate
time frame: Day 180
measure: Biomarkers of systemic inflammation and of epithelial and endothelial aggression
time frame: Day 0
description: Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
measure: Biomarkers of systemic inflammation and of epithelial and endothelial aggression
time frame: Day 1
description: Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
arm group label: Intervention group_MRA
arm group type: Experimental
description: Recruitment maneuvers and high PEEP
arm group label: Control group
arm group type: Active Comparator
description: No recruitment maneuvers and low PEEP
intervention type: Procedure
intervention name: Intervention group_MRA
description: Tidal Volume (Vt) =6-8 mL/kg of predicted body weight (PBW), Peep=8 cmH2O, recruitment maneuvers=30cm H2O every 30 min after intubation (except during CPB), after any disconnection and at the admission in ICU.
Recruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg.
Ventilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O
arm group label: Intervention group_MRA
other name: recruitment maneuvers
intervention type: Procedure
intervention name: Control group
description: Vt=6-8 mL/kg of PBW, Peep=5 cmH2O , No recruitment maneuvers. Ventilation maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O.
arm group label: Control group
other name: NO recruitment maneuvers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie DEMAURE
role: Principal Investigator
affiliation: CHU Rennes
last name: Nicolas NESSELER, Dr
role: Principal Investigator
affiliation: CHU Rennes
last name: Jean-Ferréol OILLEAU, Dr
role: Principal Investigator
affiliation: CHRU Brest
last name: Emmanuelle LONGEAU, Dr
role: Principal Investigator
affiliation: University Hospital, Angers
last name: Bertrand ROZEC, Pr
role: Principal Investigator
affiliation: CHU Nantes
last name: Thomas KERFONE, Dr
role: Principal Investigator
affiliation: CHU Poitiers
last name: Fabien ESPITALIER, Dr
role: Principal Investigator
affiliation: CHRU Tours
last name: Osama ABOU ARAB, Dr
role: Principal Investigator
affiliation: CHU Amiens-Picardie
last name: Nathalie DEMAURE
phone: 299284321
email: nathalie.demaure@chu-rennes.fr
last name: Nicolas NESSELER, Dr
email: nicolas.nesseler@chu-rennes.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No