<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/NCT02189512</url>
  </required_header>
  <id_info>
    <org_study_id>IMMO-20140206</org_study_id>
    <nct_id>NCT02189512</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Surgical Intestinal Manipulation</brief_title>
  <acronym>IMMO</acronym>
  <official_title>CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to study the impact of brain death and surgical small bowel&#xD;
      manipulation on the release of different types of monocytes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>subtypes of monocytes</measure>
    <time_frame>1 day</time_frame>
    <description>evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluate effect of intestinal manipulation</measure>
    <time_frame>1 day</time_frame>
    <description>evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Intestinal Manipulation</condition>
  <arm_group>
    <arm_group_label>brain death organ donors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>cases - blood sampling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abdominal aortic aneurysm repair</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>controls - blood sampling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampling</intervention_name>
    <description>cases - blood sampling controles - blood sampling</description>
    <arm_group_label>abdominal aortic aneurysm repair</arm_group_label>
    <arm_group_label>brain death organ donors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are brain death&#xD;
&#xD;
          -  patients who undergo an elective abdominal aortic aneurysm repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#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>Jacques Pirenne, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurens Ceulemans, MD</last_name>
    <phone>+32 16 341545</phone>
    <email>Ceulemans.laurens@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>May 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain-death organ donors</keyword>
  <keyword>intestinal manipulation</keyword>
  <keyword>monocytes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Death</mesh_term>
  </condition_browse>
  <!-- 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/NCT02189512
org study id: IMMO-20140206
nct id: NCT02189512
lead sponsor: 
has dmc: No
The aim of this study is to study the impact of brain death and surgical small bowel
      manipulation on the release of different types of monocytes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: subtypes of monocytes
time frame: 1 day
description: evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection
measure: evaluate effect of intestinal manipulation
time frame: 1 day
description: evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines
arm group label: brain death organ donors
arm group type: Other
description: cases - blood sampling
arm group label: abdominal aortic aneurysm repair
arm group type: Other
description: controls - blood sampling
intervention type: Other
intervention name: blood sampling
description: cases - blood sampling controles - blood sampling
arm group label: abdominal aortic aneurysm repair
arm group label: brain death organ donors
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacques Pirenne, MD,PhD
role: Principal Investigator
affiliation: Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
last name: Laurens Ceulemans, MD
phone: +32 16 341545
email: Ceulemans.laurens@gmail.com
facility: 
status: Recruiting
country: Belgium
responsible party type: Sponsor
mesh term: Brain Death