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

Laval University

Status: Completed

Conditions: Traumatic Brain Injury; Transfusion

Treatments: Procedure: Red Blood Cells Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03260478

MP-20-2018-3706

Details and patient eligibility

About

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.

Enrollment: 742 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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742 participants in 2 patient groups

Liberal Transfusion Strategy

Experimental group

Description:

Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.

Treatment:

Procedure: Red Blood Cells Transfusion

Restrictive Transfusion Strategy

Experimental group

Description:

Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.

Treatment:

Procedure: Red Blood Cells Transfusion