Clinical trial NCT03260478: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Official title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Canadian Traumatic Brain Injury Research Consortium
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
First posted: 2017-08-24
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: extended Glasgow Outcome Scale (GOSe)
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: ICU, Hospital and at 6 months
measure: Functional Independence Measure (FIM)
timeFrame: 6 months
measure: Quality of life (EQ-5D)
timeFrame: 6 months
measure: Quality of life (Qolibri questionnaires)
timeFrame: 6 months
measure: Depression (PHQ-9)
timeFrame: 6 months
Other outcomes:
measure: Number RBC transfusions
timeFrame: While in the ICU, censored at 6 months after randomization
measure: Lowest Daily Hemoglobin
timeFrame: While in the ICU, censored at 6 months after randomization
measure: Infections
timeFrame: While in the ICU, censored at 6 months after randomization
measure: Duration of mechanical ventilation
timeFrame: While in the ICU, censored at 6 months after randomization
measure: ICU Lenght of stay
timeFrame: While in the ICU, censored at 6 months after randomization
measure: Hospital Lenght of stay
timeFrame: While in the hospital, censored at 6 months after randomization
measure: Complications related to transfusion
timeFrame: While in the ICU, censored at 6 months after randomization
Locations:
city: Barretos
country: Brazil
facility: Santa Casa de Misericórdia de Barretos
state: Sao Paulo
city: São Paulo
country: Brazil
facility: The Hospital das Clinicas da Facudade de Medicina da USP
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Center
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS De l'Estrie
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS Mauricie-et-Centre-du-Québec
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Québec
country: Canada
facility: CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne-Rhône-Alpes
city: Besançon
country: France
facility: CHU de Besançon
state: Bourgogne-Franche-Comté
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
state: Grand Est
city: Nîmes
country: France
facility: CHU de Nîmes
state: Occitanie
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: Liverpool
country: United Kingdom
facility: Walton Centre
city: London
country: United Kingdom
facility: St. Mary's Hospital (Imperial College Healthcare)
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Nottingham
country: United Kingdom
facility: University of Nottingham Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: CHU de Quebec-Université Laval Research Center
name: Alexis Turgeon, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Quebec-Université Laval Research Center
name: François Lauzier, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Dean Fergusson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.