<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/NCT03767127</url>
  </required_header>
  <id_info>
    <org_study_id>OEDT</org_study_id>
    <nct_id>NCT03767127</nct_id>
  </id_info>
  <brief_title>Oxygen Extraction-guided Transfusion in Critically Ill Patients</brief_title>
  <official_title>Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Ferrara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Ferrara</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>
      Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU&#xD;
      course. The optimal management red blood cells RBC transfusion in critically ill patients&#xD;
      remains controversial and clinical studies in this field have usually been based on&#xD;
      transfusion thresholds. In the &quot;TRICC&quot; Trial, patients assigned to a restrictive transfusion&#xD;
      strategy (transfusion if Hb&lt;7 g/dL) had similar mortality to patients transfused if Hb&lt;10&#xD;
      g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion&#xD;
      protocol, i.e. a transfusion protocol which address the individual need for transfusion&#xD;
      basing on physiological approach. We therefore hypothesized that patients with high&#xD;
      extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>90-day mortality</measure>
    <time_frame>after 90 days from study enrollment</time_frame>
    <description>mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>7 days after study inclusion</time_frame>
    <description>Occurence of acute kidney injury according to KDIGO 2012 guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>from ICU admission to discharge, up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in Sequential Organ Failure Assessment (SOFA) score</measure>
    <time_frame>5 days</time_frame>
    <description>daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of vasopressor</measure>
    <time_frame>28 days after study inclusion</time_frame>
    <description>Need for vasopressor</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">177</enrollment>
  <condition>Anemia</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Appropriate transfusion policy</arm_group_label>
    <description>Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (&lt;3.7 ml/dl)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Appropriate transfusion policy</arm_group_label>
    <description>Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Unselected critically ill patients admitted to intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin level &lt;10 g/dL during the first 72 hours of ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute bleeding&#xD;
&#xD;
          -  Hemoglobin level less than 7 g/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Università di Ferrara</name>
      <address>
        <city>Ferrara</city>
        <zip>44121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Ferrara</investigator_affiliation>
    <investigator_full_name>Alberto Fogagnolo</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>transfusion</keyword>
  <keyword>intensive care medicine</keyword>
  <keyword>90-day mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03767127
org study id: OEDT
nct id: NCT03767127
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU
      course. The optimal management red blood cells RBC transfusion in critically ill patients
      remains controversial and clinical studies in this field have usually been based on
      transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion
      strategy (transfusion if Hb<7 g/dL) had similar mortality to patients transfused if Hb<10
      g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion
      protocol, i.e. a transfusion protocol which address the individual need for transfusion
      basing on physiological approach. We therefore hypothesized that patients with high
      extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin
      levels.
observational model: Cohort
time perspective: Prospective
measure: 90-day mortality
time frame: after 90 days from study enrollment
description: mortality
measure: Acute kidney injury
time frame: 7 days after study inclusion
description: Occurence of acute kidney injury according to KDIGO 2012 guidelines
measure: Length of ICU stay
time frame: from ICU admission to discharge, up to 8 weeks
measure: Variation in Sequential Organ Failure Assessment (SOFA) score
time frame: 5 days
description: daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)
measure: Days of vasopressor
time frame: 28 days after study inclusion
description: Need for vasopressor
arm group label: Appropriate transfusion policy
description: Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (<3.7 ml/dl)
arm group label: Non-Appropriate transfusion policy
description: Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Ferrara
investigator full name: Alberto Fogagnolo
investigator title: Principal investigator
mesh term: Critical Illness