TBI- Efficacy of Steroids in Acute Vasogenic Edema

The present protocol proposes a Pragmatic Observational Treatment Clinical Trial (P-OCT) comparing the outcome of patients with TBI and brain contusions receiving dexamethasone in the vasogenic edema phase of TBI (days 5-6, at conventional doses of 8mg/8h for five days) and patients who traditionally do not receive steroids. The primary outcomes will include the Glasgow Outcome-Extended Score (GOSE) at discharge and one month after the event, including the evolution of clinical symptoms and findings obtained through non-invasive monitoring. This approach aims to generate evidence for a comprehensive physiopathology-based study, evaluating and already used medication with a new indication in a specific condition, that can be capable of modifying the management of vasogenic edema and subsequently the outcome of TBI patients.

Inclusion criteria

• Age between 18 and 70 years.
• Mild or moderate TBI, treated in the emergency department within the first 24-72 hours post-trauma.
• Abnormal CT scan with cerebral contusion, with or without midline shift >3 mm, and/or compression of basal cisterns.
• At least 2 systems with abnormal findings on non-invasive monitoring (ONSD ≥6 mm, reduced MCV, PI >1.3 or MCA FV <20cm/sec on transcranial Doppler, or ICP waveform with P2>P1).
• Patients with or without polytrauma, with an expected survival of>24 h.
• TBI with brain contusion with medical or surgical procedures indicated within the first 24 h (ventriculostomy, cisternostomy, decompressive craniectomy, or cranial decompression).

Exclusion criteria

• Age <18 or >70 years.
• Severe TBI (GCS = 3), suspected brain death, or head AIS = 6 (non-survivable injury).
• Normal CT scan on initial assessment.
• Clinical signs of cerebral herniation upon admission.
• Severe polytrauma or massive brain injury with an expected survival <24 h.
• Pre-existing neurological disorders that interfere with outcome assessment, preexisting conditions contraindicating steroid therapy or pre-existing conditions with permanent steroid therapy.