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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
742
Transfusion of packed red blood cells unit(s).
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
extended Glasgow Outcome Scale (GOSe)
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Time frame: 6 months
Mortality
Assessment of patient mortality.
Time frame: ICU, Hospital and at 6 months
Functional Independence Measure (FIM)
Assessment of patient function.
Time frame: 6 months
Quality of life (EQ-5D)
Evaluation of the overall quality of life.
Time frame: 6 months
Quality of life (Qolibri questionnaires)
Evaluation of the quality of life specific to the TBI.
Time frame: 6 months
Depression (PHQ-9)
Assessment of depression.
Time frame: 6 months
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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
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