Schedule of enrolment, interventions, data collection and outcome assessments
| Trauma | ICU | Hospital | 6 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.