TBI- Efficacy of Steroids in Acute Vasogenic Edema

Sponsor
Meditech Foundation
Study ID
NCT07358312
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jan 22, 2026
Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Mar 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
280 participants (estimated)

Arms

  • Arm: Treatment Group
    Patients with TBI and Dexamethasone Treatment after 5 days of Trauma
  • Arm: Control Group
    Patients with TBI without Dexamethasone Treatment after 5 days of Trauma

Primary Outcome Measure

Score of every patient in the Glasgow Outcome Scale - Extended (GOS-E) one month after the event [ Time Frame: 1 month after injury, assessed in person or by phone, according to the GOS-E manual (Wilson L et al. A Manual for the Glasgow Outcome Scale-Extended Interview. J Neurotrauma. 2021 Sep 1;38 (17):2435-2446. doi: 10.1089/neu.2020.7527. PMID: 33740873 ]

Central Contacts

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