<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/NCT02203292</url>
  </required_header>
  <id_info>
    <org_study_id>32520914.3.0000.0068</org_study_id>
    <nct_id>NCT02203292</nct_id>
  </id_info>
  <brief_title>Transfusion Requirements After Head Trauma</brief_title>
  <acronym>TRAHT</acronym>
  <official_title>Transfusion Requirements After Head Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two&#xD;
      red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin difference</measure>
    <time_frame>14 days</time_frame>
    <description>Hemoglobin difference between restrictive and liberal groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of transfused patients</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of red blood cell packages transfused</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>180 days mortality</measure>
    <time_frame>Participants will be followed for 180 after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood stream infection</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
    <description>Positive blood culture with a pathogenic microorganism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-bleeding</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of measures to reduce intracranial pressure</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
    <description>Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation free days</measure>
    <time_frame>28 days</time_frame>
    <description>Days breathing without assistance from hospital admission to day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extended Glasgow Outcome Scale at hospital discharge</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extended Glasgow Outcome Scale after 6 months</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Respiratory Distress Syndrome</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Septic Shock</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral autoregulation</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
    <description>Cerebral autoregulation as measure by the transcranial doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsatility index</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 4 weeks</time_frame>
    <description>Pulsatility index as measure by the transcranial doppler</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Liberal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb &lt; 9.0 g/dL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb &lt; 7.0 g/dL</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Liberal transfusion strategy</intervention_name>
    <description>Patients will have red blood cells transfused only if Hb &lt; 9.0 g/dL</description>
    <arm_group_label>Liberal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Restrictive transfusion strategy</intervention_name>
    <description>Patients will have red blood cells transfused only if Hb &lt; 7.0 g/dL</description>
    <arm_group_label>Restrictive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal to or greater than 18 years&#xD;
&#xD;
          -  Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or&#xD;
             equal to 12 at hospital admission&#xD;
&#xD;
          -  Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glasgow coma scale equal to 3 with dilated pupils bilaterally&#xD;
&#xD;
          -  Previous neurological sequelae&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Jehovah's Witnesses&#xD;
&#xD;
          -  Hemorrhagic shock at randomization&#xD;
&#xD;
          -  Moribund patients&#xD;
&#xD;
          -  Unable to provide consent&#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>André LN Gobatto, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2016</last_update_submitted>
  <last_update_submitted_qc>July 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>André Luiz Nunes Gobatto</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Blood Transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Craniocerebral Trauma</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/NCT02203292
org study id: 32520914.3.0000.0068
nct id: NCT02203292
lead sponsor: 
has dmc: No
TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two
      red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemoglobin difference
time frame: 14 days
description: Hemoglobin difference between restrictive and liberal groups
measure: Number of transfused patients
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Number of red blood cell packages transfused
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: ICU mortality
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Hospital mortality
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: 180 days mortality
time frame: Participants will be followed for 180 after hospital discharge
measure: Blood stream infection
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
description: Positive blood culture with a pathogenic microorganism
measure: Re-bleeding
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Intensity of measures to reduce intracranial pressure
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
description: Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation
measure: Hospital length of stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: ICU length of stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Mechanical ventilation free days
time frame: 28 days
description: Days breathing without assistance from hospital admission to day 28.
measure: Extended Glasgow Outcome Scale at hospital discharge
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Extended Glasgow Outcome Scale after 6 months
time frame: 180 days
measure: Myocardial Infarction
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Acute Respiratory Distress Syndrome
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Septic Shock
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Cerebral autoregulation
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
description: Cerebral autoregulation as measure by the transcranial doppler
measure: Pulsatility index
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
description: Pulsatility index as measure by the transcranial doppler
arm group label: Liberal
arm group type: Active Comparator
description: Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
arm group label: Restrictive
arm group type: Experimental
description: Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
intervention type: Behavioral
intervention name: Liberal transfusion strategy
description: Patients will have red blood cells transfused only if Hb < 9.0 g/dL
arm group label: Liberal
intervention type: Behavioral
intervention name: Restrictive transfusion strategy
description: Patients will have red blood cells transfused only if Hb < 7.0 g/dL
arm group label: Restrictive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: André LN Gobatto, M.D.
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: André Luiz Nunes Gobatto
investigator title: M.D.
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Craniocerebral Trauma