<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/NCT03041974</url>
  </required_header>
  <id_info>
    <org_study_id>IMIB PHRC 2013</org_study_id>
    <nct_id>NCT03041974</nct_id>
  </id_info>
  <brief_title>Impact of Microparticles in Blood on Transfused Patient Outcomes</brief_title>
  <acronym>IMIB</acronym>
  <official_title>Cell-derived Microparticles in Red Blood Cell (RBC) Concentrates, and Their Potential Impact on Outcomes of Transfused Patients in Critical Care: a Prospective Multicentre National Cohort Study of Patients Included in the ABLE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During storage, red blood cells (RBCs) undergo changes collectively termed &quot;Storage lesions&quot;.&#xD;
      these changes may have an impact of the outcomes of transfused patients. One of these changes&#xD;
      is the release of microparticles by RBCs and other blood cells types. The aim of the study is&#xD;
      to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2)&#xD;
      evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion&#xD;
      complications in critical care patients participating in the ABLE trial (ISRCTN44878718).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During conservation of red blood cell concentrates, red blood cells (RBCs) undergo&#xD;
      biochemical and morphological changes that have been well described, and are collectively&#xD;
      termed &quot; storage lesions &quot;. The exact effects of these lesions in terms of beneficial or&#xD;
      deleterious implications in the recipient remain to be elucidated. However, several&#xD;
      retrospective studies in targeted populations suggest that an increase in the duration of RBC&#xD;
      conservation could lead to an increase in morbidity and mortality in transfused patients. The&#xD;
      multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to&#xD;
      evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates&#xD;
      on several outcomes in critical care patients.&#xD;
&#xD;
      Among the modifications that RBCs undergo during storage, the generation of microparticles&#xD;
      from red blood cellsRBCs or residual platelets present in the blood concentrate has never&#xD;
      been evaluated in a prospective clinical study. It has been reported that the number of red&#xD;
      cell-derived microparticles (RMPs) present in stored blood increases with storage duration.&#xD;
      In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably&#xD;
      due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that&#xD;
      the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the&#xD;
      investigative team has shown that microparticles derived from elsewhere (endothelial cells)&#xD;
      are capable of activating cells which are important in the induction of immune responses&#xD;
      (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate&#xD;
      in post-transfusional alloimmunization which may also be evaluated in this study.&#xD;
&#xD;
      The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles&#xD;
      MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused&#xD;
      microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE&#xD;
      trial in France.&#xD;
&#xD;
      Other aims are to investigate the relationship between the number of microparticles in RBC&#xD;
      units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare&#xD;
      the blood products (to define a potential new &quot;lesion storage&quot; marker).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>All cause mortality</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>28 days, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multi organ dysfunction score</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nosocomial infection</measure>
    <time_frame>6 months</time_frame>
    <description>including Nosocomial pneumonia, Deep tissue infections (e.g. peritonitis, mediastinitis), Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intensive care and Hospital duration of stay</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Length of time requiring respiratory, haemodynamic and renal support</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">280</enrollment>
  <condition>Critical Care</condition>
  <arm_group>
    <arm_group_label>Transfused critical care patients</arm_group_label>
    <description>Patients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Red Blood Cell transfusion</intervention_name>
    <arm_group_label>Transfused critical care patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microparticles quantification</intervention_name>
    <description>Flow cytometric quantification of microparticles in transfused blood</description>
    <arm_group_label>Transfused critical care patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in the study are the patients enrolled, by french centers, in either&#xD;
        arms of the ABLE trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria are those of the ABLE trial: patients who&#xD;
&#xD;
          -  Have had a request for a first red cell unit transfusion in the Intensive Care Unit&#xD;
             (ICU), and&#xD;
&#xD;
          -  Have an anticipated length of invasive and/or non-invasive continuous positive airway&#xD;
             pressure (CPAP) or bi-level positive airway pressure (BIPAP) mechanical ventilation of&#xD;
             at least 48 hours once enrolled, as estimated by the attending physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years of age&#xD;
&#xD;
          -  previously enrolled in the ABLE study&#xD;
&#xD;
          -  has already been transfused with red cells during the current hospitalisation&#xD;
&#xD;
          -  has an obvious terminal illness documented in the medical record with a life&#xD;
             expectancy of less than 3 months&#xD;
&#xD;
          -  has undergone routine cardiac surgical care&#xD;
&#xD;
          -  decision to withdraw/withhold some critical care had been made&#xD;
&#xD;
          -  brain dead&#xD;
&#xD;
          -  no red cells with a storage time of 7 days or less available in the blood bank that&#xD;
             cannot be transported from the blood supplier&#xD;
&#xD;
          -  Who require more than 1 unit of uncross-matched red cells&#xD;
&#xD;
          -  With a known objection to blood transfusions&#xD;
&#xD;
          -  With autologous blood donations&#xD;
&#xD;
          -  Who pose difficulties in securing blood products (rare blood groups), and who are&#xD;
             difficult to match&#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>Francine Garnache-Ottou, PharmD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Etablissement Français du Sang, Besançon</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 12, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Red Blood Cell Transfusion</keyword>
  <keyword>Cell-Derived Microparticles</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/NCT03041974
org study id: IMIB PHRC 2013
nct id: NCT03041974
lead sponsor: 
has dmc: No
During storage, red blood cells (RBCs) undergo changes collectively termed "Storage lesions".
      these changes may have an impact of the outcomes of transfused patients. One of these changes
      is the release of microparticles by RBCs and other blood cells types. The aim of the study is
      to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2)
      evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion
      complications in critical care patients participating in the ABLE trial (ISRCTN44878718).
During conservation of red blood cell concentrates, red blood cells (RBCs) undergo
      biochemical and morphological changes that have been well described, and are collectively
      termed " storage lesions ". The exact effects of these lesions in terms of beneficial or
      deleterious implications in the recipient remain to be elucidated. However, several
      retrospective studies in targeted populations suggest that an increase in the duration of RBC
      conservation could lead to an increase in morbidity and mortality in transfused patients. The
      multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to
      evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates
      on several outcomes in critical care patients.

      Among the modifications that RBCs undergo during storage, the generation of microparticles
      from red blood cellsRBCs or residual platelets present in the blood concentrate has never
      been evaluated in a prospective clinical study. It has been reported that the number of red
      cell-derived microparticles (RMPs) present in stored blood increases with storage duration.
      In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably
      due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that
      the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the
      investigative team has shown that microparticles derived from elsewhere (endothelial cells)
      are capable of activating cells which are important in the induction of immune responses
      (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate
      in post-transfusional alloimmunization which may also be evaluated in this study.

      The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles
      MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused
      microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE
      trial in France.

      Other aims are to investigate the relationship between the number of microparticles in RBC
      units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare
      the blood products (to define a potential new "lesion storage" marker).
observational model: Cohort
time perspective: Prospective
measure: All cause mortality
time frame: 90 days
measure: All cause mortality
time frame: 28 days, 6 months
measure: Multi organ dysfunction score
time frame: 6 months
measure: Nosocomial infection
time frame: 6 months
description: including Nosocomial pneumonia, Deep tissue infections (e.g. peritonitis, mediastinitis), Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU
measure: Intensive care and Hospital duration of stay
time frame: 6 months
measure: Length of time requiring respiratory, haemodynamic and renal support
time frame: 6 months
arm group label: Transfused critical care patients
description: Patients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center.
intervention type: Procedure
intervention name: Red Blood Cell transfusion
arm group label: Transfused critical care patients
intervention type: Procedure
intervention name: Microparticles quantification
description: Flow cytometric quantification of microparticles in transfused blood
arm group label: Transfused critical care patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francine Garnache-Ottou, PharmD, PhD
role: Principal Investigator
affiliation: Etablissement Français du Sang, Besançon
responsible party type: Sponsor
sharing ipd: No