TBI- Efficacy of Steroids in Acute Vasogenic Edema
ConditionTraumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorMeditech Foundation
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
280 Participants
are grouped into 2 trial groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov