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
This trial does not accept healthy volunteersQualifiers
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 population
This study will include a prospective cohort of patients with TBI and no history of pre-existing neurological disorders that could interfere with outcome assessment. Patients must be treated in emergency departments within 24 to 72 hours after the traumatic event and need to have a CT scan ordered as part of the initial assessment. Patients must have a documented cerebral contusion on CT and evidence of progressive vasogenic edema confirmed by the initial and subsequent imaging. Patients can present clinical symptoms (headache, blurred vision, dizziness, nausea) and at least one documented abnormality in 2 non-invasive monitoring systems (ONSD ≥6 mm, pupillometry MCV reduced, transcranial Doppler with a PI \>1.3 or an MCA flow velocity \<20cm/sec, or ICP waveform with P2\>P1 in any skull side)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
280 Participants
are grouped into 2 trial groupsGroup A: Treatment Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Score of every patient in the Glasgow Outcome Scale - Extended (GOS-E) one month after the event
GOS-E Scoring system: Minimum Score = 1, Maximum Score = 8 Level 1 = Dead, Level 2 = Vegetative State:Condition of unawareness with only reflex responses, but with periods of spontaneous eye opening. Level 3 = Low Severe Disability; Level 4 = Upper Severe Disability: Patient who is dependent on daily support for mental or physical disability, usually a combination of both. If the patient can be left alone for more than 8 hours at home, it is the upper level of SD. If the patient cannot be left at home for more than 8 hours at home, it is a lower level of SD. Level 5 = Low Moderate Disability; Level 6 = Upper Moderate Disability: Patients have some disability such as aphasia, hemiparesis, or epilepsy and/or deficits of memory or personality, but can look after themselves. They are independent at home but dependent outside. If they can return to work even with special arrangements. GOS-E will be dichotomized into unfavorable outcome (GOS-E 1-6) and favorable outcome (GOS-E 7-8).
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: 33740873Secondary outcomes
1
Length of Stay in the Hospital
Hospital Length of Stay, since the time of the injury, up to 3 months.
Time frame
Since the time of the injury, up to 3 monthsOther outcomes
1
Symptoms (blurred vision, headache, vomiting, dizziness, amnesia)
Type and number of symptoms after the treatment period, including blurred vision, headache, vomiting, dizziness, and amnesia. It will be taken from the medical records.
Time frame
Since the injury, up to 3 weeks after the injury2
Infections (surgical site infection, pneumonia, urinary tract infections, meningitis, bacteremia)
Local or Systemic Infections, including surgical site infection, pneumonia, urinary tract infections, meningitis, and bacteremia. It will be recorded from the medical record.
Time frame
Since the second week of the injury, up to 1 month after the injuryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: