⁃ The pragmatic nature of this study seeks to include all consecutive patients presenting with significant TBI, regardless of whether ICB is evident at presentation. Inclusion criteria are the following:

⁃ i) Patients with severe TBI defined as GCS of ≤8, or

⁃ ii) Patients with moderate TBI defined as GCS = 9-12, admitted to ICU, with at least some ICB present on initial CT scan and any of the following:

• Requiring invasive mechanical ventilation at the time of screening

• Increased ICB on repeat CT scan compared to initial CT scan

⁃ iii) Upon randomization the patient will be able to receive the first dose of study drug in the first 3 calendar days from the time of injury

⁃ iv) ≥ 18 years of age