<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/NCT03019900</url>
  </required_header>
  <id_info>
    <org_study_id>EPTGRA</org_study_id>
    <nct_id>NCT03019900</nct_id>
  </id_info>
  <brief_title>Survey of Blood Transfusion Practices in Critically Ill Patients at High Altitude</brief_title>
  <official_title>Encuesta Sobre prácticas de transfusión de glóbulos Rojos en el Paciente crítico Atendido en Unidades de Altura</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Tecnológica Equinoccial</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Red Latinoamericana de Medicina Intensiva de Altura</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Tecnológica Equinoccial</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe current practice on red blood cell transfusion in&#xD;
      critically ill patients of intensive care units located in high altitude areas&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anemia has been identified as a common complication in the critically ill patient.&#xD;
      Approximately 40 and 60% are transfused in normal clinical practice. However transfusions are&#xD;
      not free of adverse events including: transfusion-associated lung injury, infectious&#xD;
      complications, progression of organ failure, fluid overload associated with transfusion,&#xD;
      among others. Therefore, several clinical trials have been designed to define red blood cell&#xD;
      transfusion thresholds. Mainly two groups have been compared: 1) liberal schemes in which&#xD;
      patients are transfused with higher levels of hemoglobin (generally ≤ 10 g / dL) and&#xD;
      restrictive regimens with lower levels (≤ 7 g / dL). Institutions such as the British&#xD;
      Committee for Standards in Hematology have developed recommendations in favor of restrictive&#xD;
      strategies based mainly on the TRICC (Transfusion Requirements In Critical Care) study&#xD;
      conducted by Hebert et al.&#xD;
&#xD;
      On the other hand, it is well known that as consequences of living in places at high altitude&#xD;
      physiological modifications occur in the human. One of these adaptations is the increase in&#xD;
      hemoglobin levels occurring in people living at high altitude, especially in Andean&#xD;
      residents, in whom the hypoxia promotes an increase in the production of red blood cells.&#xD;
&#xD;
      The recommendation of the restrictive strategy in the transfusion of red blood cells has been&#xD;
      adopted in several countries with numerous populations living at high altitudes, although&#xD;
      this practice has not been evaluated in these patients.&#xD;
&#xD;
      The purpose of this study is to describe the current practice on transfusion of red blood&#xD;
      cells in critical patients treated in intensive care units located in high altitude areas&#xD;
      (over 1500 m) to determine whether physicians follow the recommendations of restrictive&#xD;
      strategies.&#xD;
&#xD;
      This is an observational, non-randomized, cross-sectional survey performed with intensivists&#xD;
      of Bolivia, Colombia, Ecuador, México and Perú. The data will be collected from an on-line&#xD;
      scenaries based survey. The survey is designated to assessed the effect of severity, need of&#xD;
      surgery, severe hypoxia, and alteration in tisular perfusion as modifiers of transfusion&#xD;
      thresholds. Besides unit characteristics as geographical altitude and type of unit will be&#xD;
      collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cross sectional survey.</measure>
    <time_frame>1 day</time_frame>
    <description>the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey</description>
  </primary_outcome>
  <enrollment type="Anticipated">352</enrollment>
  <condition>Anemia</condition>
  <condition>Critically Ill</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Red blood cells transfusions</intervention_name>
    <description>The survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The records of the Latin American Intensive Medicine Research Network in high altitude&#xD;
        (RELAMI), which has members from Bolivia, Colombia, Ecuador, Mexico and Peru, will be used&#xD;
        as a contact source to identify active intensivists through the mailing list of members.&#xD;
        Trying to identify intensive care units that work above 1500 meters above sea level.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Intensivists who work in intensive care units localized above 1500 meters above sea level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fellows, retired members and pediatrics intensivists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Montero, physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Tecnológica Equinoccial</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nadia Montero, physician</last_name>
    <phone>593 995189435</phone>
    <email>nadiamonteromd@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nadia Montero</name>
      <address>
        <city>Quito</city>
        <state>Pichincha</state>
        <country>Ecuador</country>
      </address>
    </facility>
    <contact>
      <last_name>Solange Nuñez, physician</last_name>
      <phone>593 958982015</phone>
      <email>solnun@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Ecuador</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Tecnológica Equinoccial</investigator_affiliation>
    <investigator_full_name>Nadia Montero</investigator_full_name>
    <investigator_title>clinical researcher</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>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/NCT03019900
org study id: EPTGRA
nct id: NCT03019900
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to describe current practice on red blood cell transfusion in
      critically ill patients of intensive care units located in high altitude areas
Anemia has been identified as a common complication in the critically ill patient.
      Approximately 40 and 60% are transfused in normal clinical practice. However transfusions are
      not free of adverse events including: transfusion-associated lung injury, infectious
      complications, progression of organ failure, fluid overload associated with transfusion,
      among others. Therefore, several clinical trials have been designed to define red blood cell
      transfusion thresholds. Mainly two groups have been compared: 1) liberal schemes in which
      patients are transfused with higher levels of hemoglobin (generally ≤ 10 g / dL) and
      restrictive regimens with lower levels (≤ 7 g / dL). Institutions such as the British
      Committee for Standards in Hematology have developed recommendations in favor of restrictive
      strategies based mainly on the TRICC (Transfusion Requirements In Critical Care) study
      conducted by Hebert et al.

      On the other hand, it is well known that as consequences of living in places at high altitude
      physiological modifications occur in the human. One of these adaptations is the increase in
      hemoglobin levels occurring in people living at high altitude, especially in Andean
      residents, in whom the hypoxia promotes an increase in the production of red blood cells.

      The recommendation of the restrictive strategy in the transfusion of red blood cells has been
      adopted in several countries with numerous populations living at high altitudes, although
      this practice has not been evaluated in these patients.

      The purpose of this study is to describe the current practice on transfusion of red blood
      cells in critical patients treated in intensive care units located in high altitude areas
      (over 1500 m) to determine whether physicians follow the recommendations of restrictive
      strategies.

      This is an observational, non-randomized, cross-sectional survey performed with intensivists
      of Bolivia, Colombia, Ecuador, México and Perú. The data will be collected from an on-line
      scenaries based survey. The survey is designated to assessed the effect of severity, need of
      surgery, severe hypoxia, and alteration in tisular perfusion as modifiers of transfusion
      thresholds. Besides unit characteristics as geographical altitude and type of unit will be
      collected.
time perspective: Cross-Sectional
measure: Cross sectional survey.
time frame: 1 day
description: the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey
intervention type: Procedure
intervention name: Red blood cells transfusions
description: The survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nadia Montero, physician
role: Principal Investigator
affiliation: Universidad Tecnológica Equinoccial
last name: Nadia Montero, physician
phone: 593 995189435
email: nadiamonteromd@gmail.com
facility: 
contact: 
country: Ecuador
responsible party type: Principal Investigator
investigator affiliation: Universidad Tecnológica Equinoccial
investigator full name: Nadia Montero
investigator title: clinical researcher
mesh term: Critical Illness
sharing ipd: No