Traumatic Brain InjuryHEMOTIONNCT03260478
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
A study testing Red Blood Cells Transfusion in people with Traumatic Brain Injury and Transfusion, run by CHU de Quebec-Universite Laval at 33 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Transfusion
- What is being tested?
- Red Blood Cells Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 33 sitesin 4 countries
- Study dates
- 31 Aug 2017to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute moderate to severe blunt TBI
- Glasgow Coma Score [GCS] ≤ 12
- Hb level ≤ 100 g/L
Who cannot join
- 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
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
Canada18 sites
Foothills Medical Center
Calgary, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Hamilton Health Sciences Center
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences Center
London, Ontario
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
McGill University Health Center
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval
Québec
Regina General Hospital
Regina, Saskatchewan
CIUSSS De l'Estrie
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Research Institute
Toronto, Ontario
CIUSSS Mauricie-et-Centre-du-Québec
Trois-Rivières, Quebec
Vancouver General Hospital
Vancouver, British Columbia
Winnipeg Health Sciences Center
Winnipeg, Manitoba
United Kingdom9 sites
University Hospital of Wales
Cardiff
Western General Hospital
Edinburgh
Aintree University Hospital
Liverpool
Walton Centre
Liverpool
St. Mary's Hospital (Imperial College Healthcare)
London
James Cook University Hospital
Middlesbrough
University of Nottingham Hospital
Nottingham
Salford Royal Hospital
Salford
Royal Stoke University Hospital
Stoke-on-Trent
France4 sites
CHU de Besançon
Besançon, Bourgogne-Franche-Comté
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes
CHU de Nîmes
Nîmes, Occitanie
Hôpital de Hautepierre
Strasbourg, Grand Est
Brazil2 sites
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo
The Hospital das Clinicas da Facudade de Medicina da USP
São Paulo
About this study
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.
- Conditions
- Traumatic Brain Injury, Transfusion
- Being tested
- Red Blood Cells 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
- Medical subject headings
- Brain Injuries, Traumatic, Anemia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Blood Cells TransfusionProcedure or surgery
Transfusion of packed red blood cells unit(s).
| Study group | Role | What they receive |
|---|---|---|
| Liberal Transfusion Strategy | Experimental | Patients will receive red blood cells transfusion if Hb ≤ 100 g/L. Receives: Procedure: Red Blood Cells Transfusion |
| Restrictive Transfusion Strategy | Experimental | Patients will receive red blood cells transfusion if Hb ≤ 70 g/L. Receives: Procedure: Red Blood Cells Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
extended Glasgow Outcome Scale (GOSe)
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Measured: 6 months
Secondary outcomes (5)
Mortality
Assessment of patient mortality.
Measured: ICU, Hospital and at 6 months
Functional Independence Measure (FIM)
Assessment of patient function.
Measured: 6 months
Quality of life (EQ-5D)
Evaluation of the overall quality of life.
Measured: 6 months
Quality of life (Qolibri questionnaires)
Evaluation of the quality of life specific to the TBI.
Measured: 6 months
Depression (PHQ-9)
Assessment of depression.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start31 Aug 2017
- Primary completion26 Oct 2023
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr Alexis Turgeon, CHU de Quebec-Universite Laval
- Investigators
- Alexis Turgeon, MD MSc FRCPC, Principal investigator, CHU de Quebec-Université Laval Research CenterFrançois Lauzier, MD MSc FRCPC, Principal investigator, CHU de Quebec-Université Laval Research CenterDean Fergusson, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260478
- Sponsor's protocol ID
- MP-20-2018-3706
- Acronym
- HEMOTION
- Status last verified
- May 2024
- First submitted
- 22 Aug 2017
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Turgeon AF, Fergusson DA, Clayton L, Patton MP, Neveu X, Walsh TS, Docherty A, Malbouisson LM, Pili-Floury S, English SW, Zarychanski R, Moore L, Bonaventure PL, Laroche V, Verret M, Scales DC, Adhikari NKJ, Greenbaum J, Kramer A, Rey VG, Ball I, Khwaja K, Wise M, Harvey D, Lamontagne F, Chabanne R, Algird A, Krueper S, Pottecher J, Zeiler F, Rhodes J, Rigamonti A, Burns KEA, Marshall J, Griesdale DE, Sisconetto LS, Kutsogiannis DJ, Roger C, Green R, Boyd JG, Wright J, Charbonney E, Nair P, Astles T, Sy E, Hebert PC, Chasse M, Gomez A, Ramsay T, Taljaard M, Fox-Robichaud A, Tinmouth A, St-Onge M, Costerousse O, Lauzier F; HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium. Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. N Engl J Med. 2024 Aug 22;391(8):722-735. doi: 10.1056/NEJMoa2404360. Epub 2024 Jun 13.
PubMed 38869931Turgeon 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.
PubMed 36216432
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
- ClinicalTrials.gov ID
- NCT03260478
- Acronym / sponsor ID
- HEMOTION / MP-20-2018-3706
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- 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
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Transfusion Strategy | Experimental | Procedure: Red Blood Cells TransfusionPatients will receive red blood cells transfusion if Hb ≤ 100 g/L. |
| Restrictive Transfusion Strategy | Experimental | Procedure: Red Blood Cells TransfusionPatients will receive red blood cells transfusion if Hb ≤ 70 g/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute moderate to severe blunt TBI
- Glasgow Coma Score [GCS] ≤ 12
- Hb level ≤ 100 g/L
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Blood Cells TransfusionTransfusion of packed red blood cells unit(s). | Procedure or surgery | Liberal Transfusion Strategy, Restrictive Transfusion Strategy |
Primary outcome
extended Glasgow Outcome Scale (GOSe)
Time frame: 6 months
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
5 secondary outcomes
Mortality
Time frame: ICU, Hospital and at 6 months
Functional Independence Measure (FIM)
Time frame: 6 months
Quality of life (EQ-5D)
Time frame: 6 months
Quality of life (Qolibri questionnaires)
Time frame: 6 months
Depression (PHQ-9)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 38869931Turgeon AF, Fergusson DA, Clayton L, Patton MP, Neveu X, Walsh TS, Docherty A, Malbouisson LM, Pili-Floury S, English SW, Zarychanski R, Moore L, Bonaventure PL, Laroche V, Verret M, Scales DC, Adhikari NKJ, Greenbaum J, Kramer A, Rey VG, Ball I, Khwaja K, Wise M, Harvey D, Lamontagne F, Chabanne R, Algird A, Krueper S, Pottecher J, Zeiler F, Rhodes J, Rigamonti A, Burns KEA, Marshall J, Griesdale DE, Sisconetto LS, Kutsogiannis DJ, Roger C, Green R, Boyd JG, Wright J, Charbonney E, Nair P, Astles T, Sy E, Hebert PC, Chasse M, Gomez A, Ramsay T, Taljaard M, Fox-Robichaud A, Tinmouth A, St-Onge M, Costerousse O, Lauzier F; HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium. Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. N Engl J Med. 2024 Aug 22;391(8):722-735. doi: 10.1056/NEJMoa2404360. Epub 2024 Jun 13.
- Derived from this study: PubMed 36216432Turgeon 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.
- Canadian Traumatic Brain Injury Research Consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Traumatic Brain Injury
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Recruiting
Deep Brain Reorienting in Post-traumatic Stress Disorder
PTSD, Post-traumatic Stress Disorder
Not yet recruiting
Vestibular Stimulation in Sleep for Neurorehabilitation Patients
Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Turgeon, MD MSc FRCPC principal investigator
CHU de Quebec-Université Laval Research Center
François Lauzier, MD MSc FRCPC principal investigator
CHU de Quebec-Université Laval Research Center
Dean Fergusson, PhD principal investigator
Ottawa Hospital Research Institute
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Blood Cells Transfusion in people with Traumatic Brain Injury and Transfusion, run by CHU de Quebec-Universite Laval at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Canada, United Kingdom, France, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extended Glasgow Outcome Scale (GOSe) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260478, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.