HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
NCT ID: NCT03260478
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
742 participants
INTERVENTIONAL
2017-08-31
2024-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Liberal Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Restrictive Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Interventions
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Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Eligibility Criteria
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Inclusion Criteria
* Glasgow Coma Score \[GCS\] ≤ 12
* Hb level ≤ 100 g/L
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Canadian Critical Care Trials Group
OTHER
Canadian Traumatic Brain Injury Research Consortium
UNKNOWN
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
UNKNOWN
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Dr Alexis Turgeon
Professor
Principal Investigators
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Alexis Turgeon, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec-Université Laval Research Center
François Lauzier, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec-Université Laval Research Center
Dean Fergusson, PhD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Santa Casa de Misericórdia de Barretos
Barretos, São Paulo, Brazil
The Hospital das Clinicas da Facudade de Medicina da USP
São Paulo, , Brazil
Foothills Medical Center
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Winnipeg Health Sciences Center
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Center
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
CIUSSS De l'Estrie
Sherbrooke, Quebec, Canada
CIUSSS Mauricie-et-Centre-du-Québec
Trois-Rivières, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval
Québec, , Canada
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
CHU de Besançon
Besançon, Bourgogne-Franche-Comté, France
Hôpital de Hautepierre
Strasbourg, Grand Est, France
CHU de Nîmes
Nîmes, Occitanie, France
University Hospital of Wales
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
Walton Centre
Liverpool, , United Kingdom
St. Mary's Hospital (Imperial College Healthcare)
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
University of Nottingham Hospital
Nottingham, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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Canadian Traumatic Brain Injury Research Consortium website
Other Identifiers
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MP-20-2018-3706
Identifier Type: -
Identifier Source: org_study_id
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