Clinical Trial

TBI- Efficacy of Steroids in Acute Vasogenic Edema

Study acronym: TBI-SAVE
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07358312
Lead Sponsor Meditech Foundation
Conditions Traumatic Brain Injury
Enrollment 280 participants
Start Date 2026-03-01
Primary Completion 2029-03-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-22