<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/NCT03782623</url>
  </required_header>
  <id_info>
    <org_study_id>1595/2018</org_study_id>
    <nct_id>NCT03782623</nct_id>
  </id_info>
  <brief_title>Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients</brief_title>
  <acronym>EICOTRANS-p</acronym>
  <official_title>Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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 main goal of this pilot study is to assess the time course of eicosanoid profiles in&#xD;
      intensive care unit (ICU) patients requiring packed red blood cell (PRBC) transfusion.&#xD;
      Moreover we will analyze the change of levels of eicosanoids in patient plasma prior and&#xD;
      after a PRBC transfusion as well as its correlation with levels of eicosanoids in the&#xD;
      transfused PRBCs. These data will then be used to determine the estimated effect size&#xD;
      necessary for the planning of future larger studies. We hypothesize that transfusion of PRBCs&#xD;
      will modulate the eicosanoid profile in ICU patients.&#xD;
&#xD;
      According to the Protocol filed with the Institutional Review Board of the Medical University&#xD;
      of Vienna and patient's informed consent, subsequent sub analyses using samples of this study&#xD;
      (e.g., determination of extracellular vesicles in PRBC samples and patient's plasma) will be&#xD;
      performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment secondary to limited capacity during Covid-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 19, 2020</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>Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline</measure>
    <time_frame>60 minutes prior to 90 minutes after packed red blood cell transfusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients</measure>
    <time_frame>60 minutes prior to 90 minutes after packed red blood cell transfusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of plasma eicosanoid profiles in the transfused PRBCs and the change of their plasma levels in ICU patients</measure>
    <time_frame>60 minutes prior to 90 minutes after packed red blood cell transfusion</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Anemia</condition>
  <condition>Critical Illness</condition>
  <condition>Lung Transplantation</condition>
  <condition>Open Aortic Surgery</condition>
  <arm_group>
    <arm_group_label>Intensive care patients after elective open aortic surgery</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care patients after bilateral lung transplantation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Anesthetic intensive care patients, unplanned admission</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Analysis of eicosanoid profile prior to and after PRBC transfusion</intervention_name>
    <description>Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.</description>
    <arm_group_label>Anesthetic intensive care patients, unplanned admission</arm_group_label>
    <arm_group_label>Intensive care patients after bilateral lung transplantation</arm_group_label>
    <arm_group_label>Intensive care patients after elective open aortic surgery</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: routine postoperative ICU patients after open aortic surgery Group 2: routine&#xD;
        postoperative ICU patients with immunosuppression after lung transplantation Group 3: mixed&#xD;
        postoperative ICU patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years or &gt;99 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  &lt;12h since last PRBC transfusion&#xD;
&#xD;
          -  intake/administration of acetylsalicylic acid in groups 2 and 3&#xD;
&#xD;
          -  intake/administration of cysteinyl leukotriene receptor antagonists (e.g. montelukast)&#xD;
&#xD;
          -  intake/administration of celecoxib, etoricoxib, parecoxib, ibuprofen, diclofenac, and&#xD;
             naproxen in all groups&#xD;
&#xD;
          -  glucocorticoids given within 24h of transfusion in groups 1 and 3&#xD;
&#xD;
          -  treatment with calcineurin inhibitors (e.g. tacrolimus) in groups 1 and 3&#xD;
&#xD;
          -  treatment with alemtuzumab in groups 1 and 3&#xD;
&#xD;
          -  administration of protamine for heparin reversal in groups 2 and 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>David M Baron, MD, PhD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03782623
org study id: 1595/2018
nct id: NCT03782623
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main goal of this pilot study is to assess the time course of eicosanoid profiles in
      intensive care unit (ICU) patients requiring packed red blood cell (PRBC) transfusion.
      Moreover we will analyze the change of levels of eicosanoids in patient plasma prior and
      after a PRBC transfusion as well as its correlation with levels of eicosanoids in the
      transfused PRBCs. These data will then be used to determine the estimated effect size
      necessary for the planning of future larger studies. We hypothesize that transfusion of PRBCs
      will modulate the eicosanoid profile in ICU patients.

      According to the Protocol filed with the Institutional Review Board of the Medical University
      of Vienna and patient's informed consent, subsequent sub analyses using samples of this study
      (e.g., determination of extracellular vesicles in PRBC samples and patient's plasma) will be
      performed.
observational model: Cohort
time perspective: Prospective
measure: Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
measure: Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients
time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
measure: Correlation of plasma eicosanoid profiles in the transfused PRBCs and the change of their plasma levels in ICU patients
time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
arm group label: Intensive care patients after elective open aortic surgery
arm group label: Intensive care patients after bilateral lung transplantation
arm group label: Anesthetic intensive care patients, unplanned admission
intervention type: Diagnostic Test
intervention name: Analysis of eicosanoid profile prior to and after PRBC transfusion
description: Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.
arm group label: Anesthetic intensive care patients, unplanned admission
arm group label: Intensive care patients after bilateral lung transplantation
arm group label: Intensive care patients after elective open aortic surgery
Plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: David M Baron, MD, PhD
investigator title: Principle Investigator
mesh term: Critical Illness
sharing ipd: Undecided