HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Study Overview
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Brief Summary
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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.

Official Title
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HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Conditions
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Traumatic Brain Injury, Transfusion

Intervention / Treatment
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* Procedure: Red Blood Cells Transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal Transfusion Strategy<br>Patients will receive red blood cells transfusion if Hb ≤ 100 g/L. | Procedure: Red Blood Cells Transfusion<br>* Transfusion of packed red blood cells unit(s).<br>|
| Experimental: Restrictive Transfusion Strategy<br>Patients will receive red blood cells transfusion if Hb ≤ 70 g/L. | Procedure: Red Blood Cells Transfusion<br>* Transfusion of packed red blood cells unit(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extended Glasgow Outcome Scale (GOSe) | Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Assessment of patient mortality. | ICU, Hospital and at 6 months | 
| Functional Independence Measure (FIM) | Assessment of patient function. | 6 months | 
| Quality of life (EQ-5D) | Evaluation of the overall quality of life. | 6 months | 
| Quality of life (Qolibri questionnaires) | Evaluation of the quality of life specific to the TBI. | 6 months | 
| Depression (PHQ-9) | Assessment of depression. | 6 months | 
| Complications related to transfusion | Assessment of complications related to RBC transfusions. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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