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

March 5, 2024 updated by: Dr Alexis Turgeon, CHU de Quebec-Universite Laval
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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

742

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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 Besancon
    • Grand Est
      • Strasbourg, Grand Est, France
        • Hopital de Hautepierre
    • Occitanie
      • Nîmes, Occitanie, France
        • CHU de Nimes
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2017

Primary Completion (Actual)

October 26, 2023

Study Completion (Estimated)

April 15, 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 (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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