TBI- Efficacy of Steroids in Acute Vasogenic Edema

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Conditions studied: Traumatic Brain Injury

In brief

The goal of this observational study is to learn about the impact of dexamethasone treatment in traumatic brain injury patients with vasogenic edema in the second week after the trauma, administered in centers where this intervention has been considered to treat brain edema. The main question it aims to answer is: Does dexamethasone in a regimen of 8mg/8h for 5 days improve vasogenic edema in patients after 5 days of their trauma? Participants already receiving this treatment as part of their regular medical care in emergency settings, general wards, or ICU settings for TBI will be included, and data will be compared with patients with the same criteria but who do not receive the treatment.

Key facts

Study ID

NCT07358312

Run by

Meditech Foundation

People needed

280

Starts

2026-03-01

Expected to finish

2029-12-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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