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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 : September 12, 2017
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alexis Turgeon, CHU de Quebec-Universite Laval

August 22, 2017
August 24, 2017
September 12, 2017
September 1, 2017
June 1, 2021   (Final data collection date for primary outcome measure)
extended Glasgow Outcome Scale (GOSe) [ Time Frame: 6 months ]
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Same as current
Complete list of historical versions of study NCT03260478 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Open-label with blinded outcome evaluation.
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Transfusion
Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
712
Same as current
December 1, 2021
June 1, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Lucy Clayton, MSc 1 (514) 345-4931 ext 6816 Lucy.clayton@recherche-ste-justine.qc.ca
Contact: Alexis Turgeon, MD MSc FRCPC 1 (418) 649-0252 alexis.turgeon@fmed.ulaval.ca
Canada
 
 
NCT03260478
MP-20-2018-3706
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Alexis Turgeon, CHU de Quebec-Universite Laval
CHU de Quebec-Universite Laval
  • Canadian Critical Care Trials Group
  • Canadian Traumatic Brain Injury Research Consortium
  • Canadian Institutes of Health Research (CIHR)
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
CHU de Quebec-Universite Laval
September 2017

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