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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

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Transfusion Procedure: Red Blood Cells Transfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Open-label with blinded outcome evaluation.
Primary Purpose: Treatment
Official Title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liberal Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).

Experimental: Restrictive Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).




Primary Outcome Measures :
  1. extended Glasgow Outcome Scale (GOSe) [ Time Frame: 6 months ]
    Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: ICU, Hospital and at 6 months ]
    Assessment of patient mortality.

  2. Functional Independence Measure (FIM) [ Time Frame: 6 months ]
    Assessment of patient function.

  3. Quality of life (EQ-5D) [ Time Frame: 6 months ]
    Evaluation of the overall quality of life.

  4. Quality of life (Qolibri questionnaires) [ Time Frame: 6 months ]
    Evaluation of the quality of life specific to the TBI.

  5. Depression (PHQ-9) [ Time Frame: 6 months ]
    Assessment of depression.

  6. Return to work/study of patient [ Time Frame: 6 months ]
    Assessment of patient's return to work/study or comparable previous activities.

  7. Complications related to transfusion [ Time Frame: 6 months ]
    Assessment of complications related to RBC transfusions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260478


Contacts
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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

Locations
Show Show 24 study locations
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Investigators
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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
Additional Information:
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Responsible Party: Dr Alexis Turgeon, Professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03260478    
Other Study ID Numbers: MP-20-2018-3706
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Alexis Turgeon, CHU de Quebec-Universite Laval:
Traumatic Brain Injury (TBI)
Red Blood Cells (RBC) Transfusion
Intensive Care Unit (ICU)
Transfusion Threshold
Anemia
Oxygen Delivery
Neurocritical Care
Critical Care Neurology and Trauma
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System