<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/NCT03029039</url>
  </required_header>
  <id_info>
    <org_study_id>1608110</org_study_id>
    <secondary_id>ID-RCB</secondary_id>
    <nct_id>NCT03029039</nct_id>
  </id_info>
  <brief_title>Platelet-associated Inflammation in Severe Sepsis</brief_title>
  <acronym>PlatISSep</acronym>
  <official_title>Platelet-associated Inflammation in Severe Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Sepsis represents a serious public health issue characterized by a complex inflammatory&#xD;
      response. In addition to their hemostatic role, platelets display inflammatory functions by&#xD;
      secreting a variety of immunomodulatory factors and interacting with circulating immune&#xD;
      cells. The investigators postulate that, in severe sepsis, platelets become activated and&#xD;
      release amounts of different soluble inflammatory molecules that contribute to&#xD;
      sepsis-associated inflammation. First, the investigators propose to assess whether severe&#xD;
      sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful&#xD;
      platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented&#xD;
      infection, ICU patients with documented infection involving other bacterial species, compared&#xD;
      to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the&#xD;
      investigators wish to assess whether the bacterial species affects the release of platelet&#xD;
      sCD40L and by an extensive screening of platelet soluble factors, the investigators propose&#xD;
      to set up profiles of inflammatory molecules associated with the type of infection. Finally,&#xD;
      the investigators will analyze platelets' activation state and their association with&#xD;
      circulating immune, according to the type of infection. Therefore, this project is expected&#xD;
      to assess to which extent the platelet inflammatory function is super-activated in severe&#xD;
      sepsis and to identify new platelet-related biomarkers of sepsis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">July 5, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Comparison of proportion of CD40L between the 3 groups</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between the 3 groups by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of proportion of CD40L between patients with severe sepsis and blood donor voluntary</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of proportion of CD40L in Platelet poor plasma (PPP) between patients with severe sepsis and blood donor voluntary by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of proportion of CD40Lbetween patients with severe sepsis and patients with inflammatory syndrome without sepsis</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between patients with severe sepsis and patients with inflammatory syndrome without sepsis by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of CD40L</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of CD40L of patients with severe sepsis according to the different infection (S. aureus , S. pneumoniae, E. coli)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Severe Sepsis</condition>
  <arm_group>
    <arm_group_label>patients with severe sepsis</arm_group_label>
    <description>Blood samples will be collected at inclusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with inflammatory syndrome without sepsis</arm_group_label>
    <description>Blood samples will be collected at inclusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>blood donor voluntary</arm_group_label>
    <description>Blood samples will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Blood samples will be collected at inclusion.</description>
    <arm_group_label>blood donor voluntary</arm_group_label>
    <arm_group_label>patients with inflammatory syndrome without sepsis</arm_group_label>
    <arm_group_label>patients with severe sepsis</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe sepsis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        Common inclusion criteria for ICU patients : Signed informed consent, Patient affiliated or&#xD;
        entitled to a social security, aged over 18 years,&#xD;
&#xD;
          -  Criteria for blood donor voluntary : to weigh more than 50 kg&#xD;
&#xD;
          -  Criteria for severe sepsis group : Sepsis with failure of at least one organ, severe&#xD;
             sepsis for less than 72 hours, sepsis with bacteria S. aureus, S. pneumoniae or E.&#xD;
             coli.&#xD;
&#xD;
          -  Criteria for uninfectious inflammatory syndrome group : patients operate since less&#xD;
             than 24 hours of hip or knee surgery, Absence of systemic infection&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  failure to participate at the study&#xD;
&#xD;
          -  Patients with a aspirin treatment has continued throughout severe sepsis&#xD;
&#xD;
          -  Patients with an appropriate antibiotic therapy for more than 72 hours&#xD;
&#xD;
          -  Patients with a platelet transfusion in the week before inclusion or 72 hours after a&#xD;
             surgical gesture or the occurrence of sepsis&#xD;
&#xD;
          -  Patients with the platelet account is less than 30 000 per cubic millimeter the day of&#xD;
             the sampling&#xD;
&#xD;
          -  Patients with a severe sepsis who had a surgical gesture previous week the inclusion&#xD;
&#xD;
          -  All clinical sequelae or biological at the selection&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  Patients with a treatment by platelet aggregation has continued throughout severe&#xD;
             sepsis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillipe BERTHELOT, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Platelet</keyword>
  <keyword>severe sepsis</keyword>
  <keyword>inflammation</keyword>
  <keyword>S. aureus</keyword>
  <keyword>biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <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/NCT03029039
org study id: 1608110
secondary id: ID-RCB
nct id: NCT03029039
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sepsis represents a serious public health issue characterized by a complex inflammatory
      response. In addition to their hemostatic role, platelets display inflammatory functions by
      secreting a variety of immunomodulatory factors and interacting with circulating immune
      cells. The investigators postulate that, in severe sepsis, platelets become activated and
      release amounts of different soluble inflammatory molecules that contribute to
      sepsis-associated inflammation. First, the investigators propose to assess whether severe
      sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful
      platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented
      infection, ICU patients with documented infection involving other bacterial species, compared
      to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the
      investigators wish to assess whether the bacterial species affects the release of platelet
      sCD40L and by an extensive screening of platelet soluble factors, the investigators propose
      to set up profiles of inflammatory molecules associated with the type of infection. Finally,
      the investigators will analyze platelets' activation state and their association with
      circulating immune, according to the type of infection. Therefore, this project is expected
      to assess to which extent the platelet inflammatory function is super-activated in severe
      sepsis and to identify new platelet-related biomarkers of sepsis.
observational model: Case-Control
time perspective: Prospective
measure: Comparison of proportion of CD40L between the 3 groups
time frame: 1 year
description: Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between the 3 groups by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).
measure: Comparison of proportion of CD40L between patients with severe sepsis and blood donor voluntary
time frame: 1 year
description: Comparison of proportion of CD40L in Platelet poor plasma (PPP) between patients with severe sepsis and blood donor voluntary by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).
measure: Comparison of proportion of CD40Lbetween patients with severe sepsis and patients with inflammatory syndrome without sepsis
time frame: 1 year
description: Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between patients with severe sepsis and patients with inflammatory syndrome without sepsis by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).
measure: Proportion of CD40L
time frame: 1 year
description: Proportion of CD40L of patients with severe sepsis according to the different infection (S. aureus , S. pneumoniae, E. coli)
arm group label: patients with severe sepsis
description: Blood samples will be collected at inclusion.
arm group label: patients with inflammatory syndrome without sepsis
description: Blood samples will be collected at inclusion.
arm group label: blood donor voluntary
description: Blood samples will be collected.
intervention type: Other
intervention name: Blood samples
description: Blood samples will be collected at inclusion.
arm group label: blood donor voluntary
arm group label: patients with inflammatory syndrome without sepsis
arm group label: patients with severe sepsis
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Phillipe BERTHELOT, MD PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Inflammation
sharing ipd: No