<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/NCT03260478</url>
  </required_header>
  <id_info>
    <org_study_id>MP-20-2018-3706</org_study_id>
    <nct_id>NCT03260478</nct_id>
  </id_info>
  <brief_title>HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial</brief_title>
  <acronym>HEMOTION</acronym>
  <official_title>HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Critical Care Trials Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Traumatic Brain Injury Research Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Perioperative Anesthesia Clinical Trials (PACT) Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Most trauma deaths are related to traumatic brain injury (TBI). Although the management of&#xD;
      patients has improved, mortality remains unacceptably high, and half of survivors of moderate&#xD;
      and severe TBI are left with major functional impairment. Current management guidelines are&#xD;
      based on limited evidence and practice is highly variable. Most acutely ill patients with TBI&#xD;
      will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical&#xD;
      practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed&#xD;
      concerns regarding restrictive strategies, which may adversely affect clinical outcomes in&#xD;
      TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion&#xD;
      thresholds on neurological functional outcome. We hypothesize that a liberal transfusion&#xD;
      strategy improves outcomes compared to a restrictive strategy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Actual">April 13, 2023</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
    <masking_description>Open-label with blinded outcome evaluation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>extended Glasgow Outcome Scale (GOSe)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>ICU, Hospital and at 6 months</time_frame>
    <description>Assessment of patient mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of patient function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (EQ-5D)</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of the overall quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (Qolibri questionnaires)</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of the quality of life specific to the TBI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (PHQ-9)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications related to transfusion</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of complications related to RBC transfusions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">742</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Transfusion</condition>
  <arm_group>
    <arm_group_label>Liberal Transfusion Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive Transfusion Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Red Blood Cells Transfusion</intervention_name>
    <description>Transfusion of packed red blood cells unit(s).</description>
    <arm_group_label>Liberal Transfusion Strategy</arm_group_label>
    <arm_group_label>Restrictive Transfusion Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute moderate to severe blunt TBI&#xD;
&#xD;
          -  Glasgow Coma Score [GCS] ≤ 12&#xD;
&#xD;
          -  Hb level ≤ 100 g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has received transfusion after ICU admission&#xD;
&#xD;
          -  Contraindications or known objection to transfusions&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) of 3 with dilated fixed pupils.&#xD;
&#xD;
          -  Patient is brain dead&#xD;
&#xD;
          -  Active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical&#xD;
             procedure&#xD;
&#xD;
          -  A decision to withold or withdraw life-sustaining therapies was made&#xD;
&#xD;
          -  No fixed address&#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>Alexis Turgeon, MD MSc FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Quebec-Université Laval Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François Lauzier, MD MSc FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Quebec-Université Laval Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dean Fergusson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucy Clayton, MSc</last_name>
    <phone>1 (514) 345-4931</phone>
    <phone_ext>6816</phone_ext>
    <email>hemotion@crchudequebec.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexis Turgeon, MD MSc FRCPC</last_name>
    <phone>1 (418) 649-0252</phone>
    <email>alexis.turgeon@fmed.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Santa Casa de Misericórdia de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Hospital das Clinicas da Facudade de Medicina da USP</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Winnipeg Health Sciences Center</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences Center</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CIUSSS De l'Estrie</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CIUSSS Mauricie-et-Centre-du-Québec</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regina General Hospital</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne-Rhône-Alpes</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <state>Bourgogne-Franche-Comté</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital de Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <state>Grand Est</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <state>Occitanie</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Walton Centre</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital (Imperial College Healthcare)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Nottingham Hospital</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Salford Royal Hospital</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.hemotion.ca</url>
    <description>Hemotion Trial website</description>
  </link>
  <link>
    <url>https://www.ctrc-ccrt.ca</url>
    <description>Canadian Traumatic Brain Injury Research Consortium website</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
    <investigator_full_name>Dr Alexis Turgeon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury (TBI)</keyword>
  <keyword>Red Blood Cells (RBC) Transfusion</keyword>
  <keyword>Intensive Care Unit (ICU)</keyword>
  <keyword>Transfusion Threshold</keyword>
  <keyword>Anemia</keyword>
  <keyword>Oxygen Delivery</keyword>
  <keyword>Neurocritical Care</keyword>
  <keyword>Critical Care Neurology and Trauma</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>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03260478
org study id: MP-20-2018-3706
nct id: NCT03260478
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Most trauma deaths are related to traumatic brain injury (TBI). Although the management of
      patients has improved, mortality remains unacceptably high, and half of survivors of moderate
      and severe TBI are left with major functional impairment. Current management guidelines are
      based on limited evidence and practice is highly variable. Most acutely ill patients with TBI
      will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical
      practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed
      concerns regarding restrictive strategies, which may adversely affect clinical outcomes in
      TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion
      thresholds on neurological functional outcome. We hypothesize that a liberal transfusion
      strategy improves outcomes compared to a restrictive strategy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Open-label with blinded outcome evaluation.
measure: extended Glasgow Outcome Scale (GOSe)
time frame: 6 months
description: Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
measure: Mortality
time frame: ICU, Hospital and at 6 months
description: Assessment of patient mortality.
measure: Functional Independence Measure (FIM)
time frame: 6 months
description: Assessment of patient function.
measure: Quality of life (EQ-5D)
time frame: 6 months
description: Evaluation of the overall quality of life.
measure: Quality of life (Qolibri questionnaires)
time frame: 6 months
description: Evaluation of the quality of life specific to the TBI.
measure: Depression (PHQ-9)
time frame: 6 months
description: Assessment of depression.
measure: Complications related to transfusion
time frame: 6 months
description: Assessment of complications related to RBC transfusions.
arm group label: Liberal Transfusion Strategy
arm group type: Experimental
description: Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
arm group label: Restrictive Transfusion Strategy
arm group type: Experimental
description: Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
intervention type: Procedure
intervention name: Red Blood Cells Transfusion
description: Transfusion of packed red blood cells unit(s).
arm group label: Liberal Transfusion Strategy
arm group label: Restrictive Transfusion Strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexis Turgeon, MD MSc FRCPC
role: Principal Investigator
affiliation: CHU de Quebec-Université Laval Research Center
last name: François Lauzier, MD MSc FRCPC
role: Principal Investigator
affiliation: CHU de Quebec-Université Laval Research Center
last name: Dean Fergusson, PhD
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
last name: Lucy Clayton, MSc
phone: 1 (514) 345-4931
phone ext: 6816
email: hemotion@crchudequebec.ulaval.ca
last name: Alexis Turgeon, MD MSc FRCPC
phone: 1 (418) 649-0252
email: alexis.turgeon@fmed.ulaval.ca
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Brazil
country: Canada
country: France
country: United Kingdom
url: https://www.hemotion.ca
description: Hemotion Trial website
url: https://www.ctrc-ccrt.ca
description: Canadian Traumatic Brain Injury Research Consortium website
responsible party type: Principal Investigator
investigator affiliation: CHU de Quebec-Universite Laval
investigator full name: Dr Alexis Turgeon
investigator title: Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: Yes