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HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial (HEMOTION)

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ClinicalTrials.gov Identifier: NCT03260478
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr Alexis Turgeon, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE August 22, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
extended Glasgow Outcome Scale (GOSe) [ Time Frame: 6 months ]
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Mortality [ Time Frame: ICU, Hospital and at 6 months ]
    Assessment of patient mortality.
  • Functional Independence Measure (FIM) [ Time Frame: 6 months ]
    Assessment of patient function.
  • Quality of life (EQ-5D) [ Time Frame: 6 months ]
    Evaluation of the overall quality of life.
  • Quality of life (Qolibri questionnaires) [ Time Frame: 6 months ]
    Evaluation of the quality of life specific to the TBI.
  • Depression (PHQ-9) [ Time Frame: 6 months ]
    Assessment of depression.
  • Return to work/study of patient [ Time Frame: 6 months ]
    Assessment of patient's return to work/study or comparable previous activities.
  • Complications related to transfusion [ Time Frame: 6 months ]
    Assessment of complications related to RBC transfusions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Official Title  ICMJE HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Open-label with blinded outcome evaluation.
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Transfusion
Intervention  ICMJE Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Study Arms  ICMJE
  • Experimental: Liberal Transfusion Strategy
    Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
    Intervention: Procedure: Red Blood Cells Transfusion
  • Experimental: Restrictive Transfusion Strategy
    Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
    Intervention: Procedure: Red Blood Cells Transfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
712
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute moderate to severe blunt TBI
  • Glasgow Coma Score [GCS] ≤ 12
  • Hb level ≤ 100 g/L

Exclusion Criteria:

  • Patient has received transfusion after ICU admission
  • Contraindications or known objection to transfusions
  • Glasgow Coma Scale (GCS) of 3 with dilated fixed pupils.
  • Patient is brain dead
  • Active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical procedure
  • A decision to withold or withdraw life-sustaining therapies was made
  • No fixed address
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lucy Clayton, MSc 1 (514) 345-4931 ext 6816 hemotion@crchudequebec.ulaval.ca
Contact: Alexis Turgeon, MD MSc FRCPC 1 (418) 649-0252 alexis.turgeon@fmed.ulaval.ca
Listed Location Countries  ICMJE Canada,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03260478
Other Study ID Numbers  ICMJE MP-20-2018-3706
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr Alexis Turgeon, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE
  • Canadian Critical Care Trials Group
  • Canadian Traumatic Brain Injury Research Consortium
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Alexis Turgeon, MD MSc FRCPC CHU de Quebec-Université Laval Research Center
Principal Investigator: François Lauzier, MD MSc FRCPC CHU de Quebec-Université Laval Research Center
Principal Investigator: Dean Fergusson, PhD Ottawa Hospital Research Institute
PRS Account CHU de Quebec-Universite Laval
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP