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

Primary Purpose

Traumatic Brain Injury, Transfusion

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Red Blood Cells Transfusion
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Casa de Misericórdia de BarretosRecruiting
  • The Hospital das Clinicas da Facudade de Medicina da USPRecruiting
  • Foothills Medical CenterRecruiting
  • Royal Alexandra HospitalRecruiting
  • University of Alberta HospitalRecruiting
  • Vancouver General HospitalRecruiting
  • Winnipeg Health Sciences CenterRecruiting
  • Queen Elizabeth II Health Sciences CentreRecruiting
  • Hamilton Health Sciences CenterRecruiting
  • Kingston General HospitalRecruiting
  • London Health Sciences CenterRecruiting
  • The Ottawa HospitalRecruiting
  • St. Michael's HospitalRecruiting
  • Sunnybrook Research InstituteRecruiting
  • Centre Hospitalier de l'Université de MontréalRecruiting
  • McGill University Health CenterRecruiting
  • CIUSSS De l'EstrieRecruiting
  • CIUSSS Mauricie-et-Centre-du-QuébecRecruiting
  • Regina General HospitalRecruiting
  • CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université LavalRecruiting
  • CHU de Clermont-FerrandRecruiting
  • CHU de BesançonRecruiting
  • Hôpital de HautepierreRecruiting
  • CHU de NîmesRecruiting
  • University Hospital of WalesRecruiting
  • Western General HospitalRecruiting
  • Aintree University HospitalRecruiting
  • Walton CentreRecruiting
  • St. Mary's Hospital (Imperial College Healthcare)Recruiting
  • James Cook University HospitalRecruiting
  • University of Nottingham HospitalRecruiting
  • Salford Royal HospitalRecruiting
  • Royal Stoke University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Liberal Transfusion Strategy

Restrictive Transfusion Strategy

Arm Description

Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.

Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.

Outcomes

Primary Outcome Measures

extended Glasgow Outcome Scale (GOSe)
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)

Secondary Outcome Measures

Mortality
Assessment of patient mortality.
Functional Independence Measure (FIM)
Assessment of patient function.
Quality of life (EQ-5D)
Evaluation of the overall quality of life.
Quality of life (Qolibri questionnaires)
Evaluation of the quality of life specific to the TBI.
Depression (PHQ-9)
Assessment of depression.
Complications related to transfusion
Assessment of complications related to RBC transfusions.

Full Information

First Posted
August 22, 2017
Last Updated
May 1, 2023
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Critical Care Trials Group, Canadian Traumatic Brain Injury Research Consortium, Canadian Institutes of Health Research (CIHR), Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
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1. Study Identification

Unique Protocol Identification Number
NCT03260478
Brief Title
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Acronym
HEMOTION
Official Title
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Critical Care Trials Group, Canadian Traumatic Brain Injury Research Consortium, Canadian Institutes of Health Research (CIHR), Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Transfusion
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Open-label with blinded outcome evaluation.
Allocation
Randomized
Enrollment
742 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal Transfusion Strategy
Arm Type
Experimental
Arm Description
Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
Arm Title
Restrictive Transfusion Strategy
Arm Type
Experimental
Arm Description
Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
Intervention Type
Procedure
Intervention Name(s)
Red Blood Cells Transfusion
Intervention Description
Transfusion of packed red blood cells unit(s).
Primary Outcome Measure Information:
Title
extended Glasgow Outcome Scale (GOSe)
Description
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality
Description
Assessment of patient mortality.
Time Frame
ICU, Hospital and at 6 months
Title
Functional Independence Measure (FIM)
Description
Assessment of patient function.
Time Frame
6 months
Title
Quality of life (EQ-5D)
Description
Evaluation of the overall quality of life.
Time Frame
6 months
Title
Quality of life (Qolibri questionnaires)
Description
Evaluation of the quality of life specific to the TBI.
Time Frame
6 months
Title
Depression (PHQ-9)
Description
Assessment of depression.
Time Frame
6 months
Title
Complications related to transfusion
Description
Assessment of complications related to RBC transfusions.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Clayton, MSc
Phone
1 (514) 345-4931
Ext
6816
Email
hemotion@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Turgeon, MD MSc FRCPC
Phone
1 (418) 649-0252
Email
alexis.turgeon@fmed.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Turgeon, MD MSc FRCPC
Organizational Affiliation
CHU de Quebec-Université Laval Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Lauzier, MD MSc FRCPC
Organizational Affiliation
CHU de Quebec-Université Laval Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean Fergusson, PhD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa de Misericórdia de Barretos
City
Barretos
State/Province
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
The Hospital das Clinicas da Facudade de Medicina da USP
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winnipeg Health Sciences Center
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hamilton Health Sciences Center
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS De l'Estrie
City
Sherbrooke
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS Mauricie-et-Centre-du-Québec
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne-Rhône-Alpes
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Besançon
City
Besançon
State/Province
Bourgogne-Franche-Comté
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de Hautepierre
City
Strasbourg
State/Province
Grand Est
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nîmes
City
Nîmes
State/Province
Occitanie
Country
France
Individual Site Status
Recruiting
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Aintree University Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Walton Centre
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St. Mary's Hospital (Imperial College Healthcare)
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University of Nottingham Hospital
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Salford Royal Hospital
City
Salford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
36216432
Citation
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.
Results Reference
derived
Links:
URL
https://www.hemotion.ca
Description
Hemotion Trial website
URL
https://www.ctrc-ccrt.ca
Description
Canadian Traumatic Brain Injury Research Consortium website

Learn more about this trial

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

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