HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 742
- Locations
- 33
- Primary Endpoint
- extended Glasgow Outcome Scale (GOSe)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Open-label with blinded outcome evaluation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
extended Glasgow Outcome Scale (GOSe)
Time Frame: 6 months
Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
Secondary Outcomes
- Quality of life (EQ-5D)(6 months)
- Quality of life (Qolibri questionnaires)(6 months)
- Mortality(ICU, Hospital and at 6 months)
- Functional Independence Measure (FIM)(6 months)
- Depression (PHQ-9)(6 months)
Investigators
Dr Alexis Turgeon
Professor
CHU de Quebec-Universite Laval