<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/NCT02232412</url>
  </required_header>
  <id_info>
    <org_study_id>NIRS-2014</org_study_id>
    <nct_id>NCT02232412</nct_id>
  </id_info>
  <brief_title>Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients</brief_title>
  <official_title>Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Critically ill patients are frequently transfused with red blood cell (RBC) units with the&#xD;
      predominant intention to increase arterial oxygen content and thus oxygen delivery to the&#xD;
      tissues.&#xD;
&#xD;
      To date, RBC transfusions have been proven effective in patients with profound anaemia or&#xD;
      circulatory shock. However, the impact of the storage process and the so-called storage&#xD;
      lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding&#xD;
      tissue oxygenation are much debated at present. Alterations of RBC physiology have been&#xD;
      comprehensively described ex vivo. Reduced deformability, increased adhesiveness and&#xD;
      aggregability of stored RBC impair their rheological properties; anaerobic cellular&#xD;
      metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP)&#xD;
      increases oxygen affinity and impairs oxygen release to the tissues.&#xD;
&#xD;
      This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen&#xD;
      saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near&#xD;
      infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might&#xD;
      require RBC transfusion. The monitoring is continued for the time of transfusion and the&#xD;
      hours afterwards.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>regional cerebral oxygen saturation (rSO2)</measure>
    <time_frame>24-48 hours</time_frame>
    <description>Regional cerebral oxygen saturation (rSO2) will be measured before, during and after RBC transfusion. As the decision to transfuse is multifactorial and the condition of critically ill patients often instable, time frames before, during and after transfusion may vary.</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Effect of RBC Transfusions on Cerebral Oxygen Saturation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients requiring haemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  expected requirement of RBC transfusion&#xD;
&#xD;
          -  18 yrs and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe traumatic brain injury (Glasgow coma scale &lt; 9), subarachnoid hemorrhage (Hunt&#xD;
             and Hess scale ≥ 3) or intracranial hemorrhage&#xD;
&#xD;
          -  cerebral ischaemia&#xD;
&#xD;
          -  active bleeding&#xD;
&#xD;
          -  patients necessitating ongoing resuscitation&#xD;
&#xD;
          -  deficient signal of rSO2 impeding its proper valuation&#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>Kai D Zacharowski, MD, PhD, FRCA</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick Meybohm, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dania P Fischer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Dania Fischer</investigator_full_name>
    <investigator_title>Dr. Dania Fischer</investigator_title>
  </responsible_party>
  <keyword>Anemia</keyword>
  <keyword>NIRS</keyword>
  <keyword>Near Infrared Spectroscopy</keyword>
  <keyword>RBC transfusion</keyword>
  <keyword>critical ill</keyword>
  <keyword>regional cerebral oxygen saturation</keyword>
  <keyword>tissue oxygenation</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/NCT02232412
org study id: NIRS-2014
nct id: NCT02232412
lead sponsor: 
has dmc: No
Critically ill patients are frequently transfused with red blood cell (RBC) units with the
      predominant intention to increase arterial oxygen content and thus oxygen delivery to the
      tissues.

      To date, RBC transfusions have been proven effective in patients with profound anaemia or
      circulatory shock. However, the impact of the storage process and the so-called storage
      lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding
      tissue oxygenation are much debated at present. Alterations of RBC physiology have been
      comprehensively described ex vivo. Reduced deformability, increased adhesiveness and
      aggregability of stored RBC impair their rheological properties; anaerobic cellular
      metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP)
      increases oxygen affinity and impairs oxygen release to the tissues.

      This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen
      saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near
      infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might
      require RBC transfusion. The monitoring is continued for the time of transfusion and the
      hours afterwards.
observational model: Case-Only
time perspective: Prospective
measure: regional cerebral oxygen saturation (rSO2)
time frame: 24-48 hours
description: Regional cerebral oxygen saturation (rSO2) will be measured before, during and after RBC transfusion. As the decision to transfuse is multifactorial and the condition of critically ill patients often instable, time frames before, during and after transfusion may vary.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kai D Zacharowski, MD, PhD, FRCA
role: Study Director
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
last name: Patrick Meybohm, MD
role: Study Chair
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
last name: Dania P Fischer, MD
role: Principal Investigator
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Dr Dania Fischer
investigator title: Dr. Dania Fischer
mesh term: Critical Illness