<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/NCT03268668</url>
  </required_header>
  <id_info>
    <org_study_id>JDS_2017_8</org_study_id>
    <nct_id>NCT03268668</nct_id>
  </id_info>
  <brief_title>Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis</brief_title>
  <acronym>COMPO-CLOT</acronym>
  <official_title>Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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 recent validation of thrombectomy in addition to thrombolysis with intravenous&#xD;
      administration of alteplase suggests a major revolution in the management of acute strokes.&#xD;
      This treatment option also opens up a new field of research, making possible the analysis of&#xD;
      the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the&#xD;
      thrombectomy procedure makes it possible to retrieve either partially or completely the clot.&#xD;
      Previous studies have analyzed the correlation between the composition of the thrombus and&#xD;
      the etiology of stroke. Their discordant results do not yet make it possible to distinguish a&#xD;
      particular profile of thrombus according to etiology. Other studies have shown a correlation&#xD;
      between the proportion of red blood cells in a thrombus and the likelihood that it is visible&#xD;
      in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between&#xD;
      the presence of lymphocytes in the thrombus and an atheromatous etiology.&#xD;
&#xD;
      The main limitations of these studies are the small number of patients included, the high&#xD;
      variability of conservation protocols and the absence of plasma data, which does not allow&#xD;
      for research on the correlation between clot composition and plasma biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).</measure>
    <time_frame>3 months</time_frame>
    <description>Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint.&#xD;
Clinical data will be collected up to 3 months after stroke (Rankin score).</description>
  </primary_outcome>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>Biological Specimen Banks</condition>
  <condition>Biomarkers</condition>
  <condition>Etiology</condition>
  <condition>Prognosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of thrombus that is responsible for stroke and blood sample</intervention_name>
    <description>A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :&#xD;
A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase &gt; 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with ischemic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 years and older; having a cerebral infarction following arterial&#xD;
             occlusion; treated by thrombectomy; patient in whom a thrombus could be collected.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient benefiting from a legal protection measure; pregnant or breastfeeding woman&#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>Jean-Philippe Désilles, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique A. de Rothschild</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie Yavchitz, MD PhD</last_name>
    <phone>0148036454</phone>
    <phone_ext>+33</phone_ext>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean-Philippe Désilles, MD</last_name>
    <phone>0672872906</phone>
    <email>jpdesilles@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaultier MARNAT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlotte Barbier</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin GORY</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44 093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain BOURCIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Philippe Désilles, MD</last_name>
      <phone>0672872906</phone>
      <email>jdesilles@for.paris</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François EUGENE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch,</name>
      <address>
        <city>Suresnes</city>
        <zip>92 150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bertrand LAPERGUE</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT03268668
org study id: JDS_2017_8
nct id: NCT03268668
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The recent validation of thrombectomy in addition to thrombolysis with intravenous
      administration of alteplase suggests a major revolution in the management of acute strokes.
      This treatment option also opens up a new field of research, making possible the analysis of
      the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the
      thrombectomy procedure makes it possible to retrieve either partially or completely the clot.
      Previous studies have analyzed the correlation between the composition of the thrombus and
      the etiology of stroke. Their discordant results do not yet make it possible to distinguish a
      particular profile of thrombus according to etiology. Other studies have shown a correlation
      between the proportion of red blood cells in a thrombus and the likelihood that it is visible
      in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between
      the presence of lymphocytes in the thrombus and an atheromatous etiology.

      The main limitations of these studies are the small number of patients included, the high
      variability of conservation protocols and the absence of plasma data, which does not allow
      for research on the correlation between clot composition and plasma biomarkers.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).
time frame: 3 months
description: Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint.
Clinical data will be collected up to 3 months after stroke (Rankin score).
intervention type: Other
intervention name: Collection of thrombus that is responsible for stroke and blood sample
description: A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :
A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase > 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Philippe Désilles, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique A. de Rothschild
last name: Amélie Yavchitz, MD PhD
phone: 0148036454
phone ext: +33
email: ayavchitz@for.paris
last name: Jean-Philippe Désilles, MD
phone: 0672872906
email: jpdesilles@for.paris
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No