TBI- Efficacy of Steroids in Acute Vasogenic Edema

N/ANot Yet RecruitingNCT07358312

Meditech Foundation280 enrolled

Overview

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.

The present protocol proposes a Pragmatic Observational Treatment Clinical Trial (P-OCT) comparing the outcome of patients with TBI and brain contusions receiving dexamethasone in the vasogenic edema phase of TBI (days 5-6, at conventional doses of 8mg/8h for five days) and patients who traditionally do not receive steroids. The primary outcomes will include the Glasgow Outcome-Extended Score (GOSE) at discharge and one month after the event, including the evolution of clinical symptoms and findings obtained through non-invasive monitoring. This approach aims to generate evidence for a comprehensive physiopathology-based study, evaluating and already used medication with a new indication in a specific condition, that can be capable of modifying the management of vasogenic edema and subsequently the outcome of TBI patients.

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

Traumatic Brain Injury

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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: 33740873

Secondary Outcomes

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 months