Table 1

Schedule of enrolment, interventions, data collection and outcome assessments

TraumaICUHospital6 months
Enrolment
 Eligibility screen✔️
 Informed consent✔️
 Allocation✔️
Intervention—transfusion strategy
 Liberal (Hb>100 g/L) or restrictive (Hb>70 g/L)✔️
Pre-randomisation data collection*
 Demographics✔️
 Trauma characteristics✔️
 Physical examination✔️✔️
 Laboratory results✔️✔️
 Secondary insults✔️✔️
 Cointerventions✔️✔️
 Neurosurgical and non-neurosurgical interventions✔️✔️
 Blood product transfusions✔️✔️
 Transfusion reactions✔️✔️
Daily data collection
 Physical examination✔️
 Laboratory results✔️
 Secondary insults✔️
 Cointerventions✔️
 Neurosurgical and non-neurosurgical interventions✔️
 Blood product transfusions✔️
 Transfusion complications✔️✔️
 Protocol deviation/violation✔️
Trial outcomes
 Primary outcome
  Glasgow Outcome Scale extended✔︎
 Secondary outcomes
  Mortality✔️✔️✔️
  Functional Independence Measure✔️
  EuroQoL 5-Dimension 5-Level✔️
  Quality of Life after Brain Injury (QOLIBRI)✔️
  Patient Health Questionnaire-9✔️
 Tertiary outcomes
  Red blood cells transfusion✔️
  Lowest Hb✔️
  Infections✔️
  Length of mechanical ventilation✔️
  Length of stay✔️✔️
Transfusion complications✔️
  • *Performed retrospectively after randomisation.

  • Hb, haemoglobin; ICU, intensive care unit.