Protocol

Background

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.

Objectives

Primary objective:

Evaluate the effect of red blood cell transfusion thresholds on neurological functional outcome (Glasgow Outcome Scale extended) at 6 months following TBI.

Secondary objectives:

Evaluate the overall functional outcome, quality of life, psychological outcomes and mortality at 6 months.

Design

HEMOTION is a multicentre pragmatic randomized open blinded-endpoint (PROBE) trial in acutely ill TBI patients.

Population

Adult patients admitted to an intensive care unit (ICU) with an acute moderate or severe blunt traumatic brain injury and a Hb ≤ 100 g/L.

Methods

Participants will be randomly assigned to one of the two transfusion strategies. The allocated transfusion strategy will be applied from the time of randomization to death or discharge from the ICU. Daily data collection will be done and 6-month outcomes will be centrally evaluated.

Inclusion/exclusion Criteria

Inclusion criteria

  1. Age ≥ 18 years old at time of randomization
  2. Acute TBI
  3. Blunt TBI
  4. Glasgow Coma Scale (GCS) ≤ 12
  5. Hémoglobin ≤ 100 g/L

Exclusion criteria:

  1. Received a red blood cell transfusion after ICU admission
  2. Contraindications or known objection to transfusions
  3. Active life-threatening bleeding with hemorrhagic shock or requiring an urgent surgical procedure
  4. GCS of 3 with bilateral fixed dilated pupils
  5. Brain death
  6. Decision to withhold or withdraw life-sustaining therapies was made
  7. No fixed address

See ClinicalTrials.gov

 

Donation