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

Last updated: May 1, 2024
Sponsor: CHU de Quebec-Universite Laval
Overall Status: Completed

Phase

N/A

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

Red Blood Cells Transfusion

Clinical Study ID

NCT03260478
MP-20-2018-3706
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 surgicalprocedure
  • A decision to withold or withdraw life-sustaining therapies was made
  • No fixed address

Study Design

Total Participants: 742
Treatment Group(s): 1
Primary Treatment: Red Blood Cells Transfusion
Phase:
Study Start date:
August 31, 2017
Estimated Completion Date:
February 16, 2024

Connect with a study center

  • Santa Casa de Misericórdia de Barretos

    Barretos, Sao Paulo
    Brazil

    Site Not Available

  • The Hospital das Clinicas da Facudade de Medicina da USP

    São Paulo,
    Brazil

    Site Not Available

  • Foothills Medical Center

    Calgary, Alberta
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Winnipeg Health Sciences Center

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Hamilton Health Sciences Center

    Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario
    Canada

    Site Not Available

  • London Health Sciences Center

    London, Ontario
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • Sunnybrook Research Institute

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec
    Canada

    Site Not Available

  • McGill University Health Center

    Montréal, Quebec
    Canada

    Site Not Available

  • CIUSSS De l'Estrie

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • CIUSSS Mauricie-et-Centre-du-Québec

    Trois-Rivières, Quebec
    Canada

    Site Not Available

  • Regina General Hospital

    Regina, Saskatchewan
    Canada

    Site Not Available

  • CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval

    Québec,
    Canada

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Auvergne-Rhône-Alpes
    France

    Site Not Available

  • CHU de Besançon

    Besançon, Bourgogne-Franche-Comté
    France

    Site Not Available

  • Hôpital de Hautepierre

    Strasbourg, Grand Est
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes, Occitanie
    France

    Site Not Available

  • University Hospital of Wales

    Cardiff,
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh,
    United Kingdom

    Site Not Available

  • Aintree University Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Walton Centre

    Liverpool,
    United Kingdom

    Site Not Available

  • St. Mary's Hospital (Imperial College Healthcare)

    London,
    United Kingdom

    Site Not Available

  • James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Site Not Available

  • University of Nottingham Hospital

    Nottingham,
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford,
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent,
    United Kingdom

    Site Not Available

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