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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Transfusion
• Intervention / Treatment: Procedure: Red Blood Cells Transfusion

• Study Type: Interventional
• Enrollment (Actual): 742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • The Hospital das Clinicas da Facudade de Medicina da USP
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil
      • Santa Casa de Misericórdia de Barretos
• Canada
  • Québec, Canada
    • CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Medical Center
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Winnipeg Health Sciences Center
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences Center
    • Kingston, Ontario, Canada
      • Kingston General Hospital
    • London, Ontario, Canada
      • London Health Sciences Center
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Research Institute
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier de l'Université de Montréal
    • Montréal, Quebec, Canada
      • McGill University Health Center
    • Sherbrooke, Quebec, Canada
      • CIUSSS De l'Estrie
    • Trois-Rivières, Quebec, Canada
      • CIUSSS Mauricie-et-Centre-du-Québec
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Regina General Hospital
• France
  • Auvergne-Rhône-Alpes
    • Clermont-Ferrand, Auvergne-Rhône-Alpes, France
      • CHU de Clermont-Ferrand
  • Bourgogne-Franche-Comté
    • Besançon, Bourgogne-Franche-Comté, France
      • CHU de Besançon
  • Grand Est
    • Strasbourg, Grand Est, France
      • Hopital de Hautepierre
  • Occitanie
    • Nîmes, Occitanie, France
      • CHU de Nîmes
• United Kingdom
  • Cardiff, United Kingdom
    • University Hospital of wales
  • Edinburgh, United Kingdom
    • Western General Hospital
  • Liverpool, United Kingdom
    • Aintree University Hospital
  • Liverpool, United Kingdom
    • Walton Centre
  • London, United Kingdom
    • St. Mary's Hospital (Imperial College Healthcare)
  • Middlesbrough, United Kingdom
    • James Cook University Hospital
  • Nottingham, United Kingdom
    • University of Nottingham Hospital
  • Salford, United Kingdom
    • Salford Royal Hospital
  • Stoke-on-Trent, United Kingdom
    • Royal Stoke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extended Glasgow Outcome Scale (GOSe)	Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Assessment of patient mortality.	ICU, Hospital and at 6 months
Functional Independence Measure (FIM)	Assessment of patient function.	6 months
Quality of life (EQ-5D)	Evaluation of the overall quality of life.	6 months
Quality of life (Qolibri questionnaires)	Evaluation of the quality of life specific to the TBI.	6 months
Depression (PHQ-9)	Assessment of depression.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number RBC transfusions	Assessment of the number of RBC transfusions.	While in the ICU, censored at 6 months after randomization
Lowest Daily Hemoglobin	Assessment of the Median Lower Daily Hemoglobin.	While in the ICU, censored at 6 months after randomization
Infections	Assessment of the incidence of infections.	While in the ICU, censored at 6 months after randomization
Duration of mechanical ventilation	Duration of mechanical ventilation.	While in the ICU, censored at 6 months after randomization
ICU Lenght of stay	Lenght of stay in the intensive care unit	While in the ICU, censored at 6 months after randomization
Hospital Lenght of stay	Duration of hospitalization is study hospital	While in the hospital, censored at 6 months after randomization
Complications related to transfusion	Assessment of complications related to RBC transfusions.	While in the ICU, censored at 6 months after randomization

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Critical Care Trials Group; Canadian Traumatic Brain Injury Research Consortium; Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
• Investigators: 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

Publications and helpful links

General Publications

• Turgeon AF, Fergusson DA, Clayton L, Patton MP, Zarychanski R, English S, Docherty A, Walsh T, Griesdale D, Kramer AH, Scales D, Burns KEA, Boyd JG, Marshall JC, Kutsogiannis DJ, Ball I, Hebert PC, Lamontagne F, Costerousse O, St-Onge M, Lessard Bonaventure P, Moore L, Neveu X, Rigamonti A, Khwaja K, Green RS, Laroche V, Fox-Robichaud A, Lauzier F; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium. Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol. BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117.

Helpful Links

• Hemotion Trial website

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Anemia; Neurocritical Care; Intensive Care Unit (ICU); Traumatic Brain Injury (TBI); Red Blood Cells (RBC) Transfusion; Transfusion Threshold; Oxygen Delivery; Critical Care Neurology and Trauma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: MP-20-2018-3706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No