Transfusion, Traumatic Brain Injury
Conditions
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
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.
Interventions
PROCEDURERed Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Sponsors
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open-label with blinded outcome evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| extended Glasgow Outcome Scale (GOSe) | 6 months | Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | ICU, Hospital and at 6 months | Assessment of patient mortality. |
| Functional Independence Measure (FIM) | 6 months | Assessment of patient function. |
| Quality of life (EQ-5D) | 6 months | Evaluation of the overall quality of life. |
| Quality of life (Qolibri questionnaires) | 6 months | Evaluation of the quality of life specific to the TBI. |
| Depression (PHQ-9) | 6 months | Assessment of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number RBC transfusions | While in the ICU, censored at 6 months after randomization | Assessment of the number of RBC transfusions. |
| Lowest Daily Hemoglobin | While in the ICU, censored at 6 months after randomization | Assessment of the Median Lower Daily Hemoglobin. |
| Infections | While in the ICU, censored at 6 months after randomization | Assessment of the incidence of infections. |
| Duration of mechanical ventilation | While in the ICU, censored at 6 months after randomization | Duration of mechanical ventilation. |
| ICU Lenght of stay | While in the ICU, censored at 6 months after randomization | Lenght of stay in the intensive care unit |
| Hospital Lenght of stay | While in the hospital, censored at 6 months after randomization | Duration of hospitalization is study hospital |
| Complications related to transfusion | While in the ICU, censored at 6 months after randomization | Assessment of complications related to RBC transfusions. |
Countries
Brazil, Canada, France, United Kingdom
Outcome results
None listed