TBI- Efficacy of Steroids in Acute Vasogenic Edema

Official title

Traumatic Brain Injury - Efficacy of Steroids in Acute Vasogenic Edema

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.

Detailed description

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.

Primary outcome measures

• 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]

Secondary outcome measures (1)

• Length of Stay in the Hospital [Time frame: Since the time of the injury, up to 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Pérez-Bárcena J, Lara M, Pomar J, et al. DEXCON-TBI: protocol for a randomized controlled trial of dexamethasone in TBI. Trials. 2021;22(1):106
• Prasad GL, Pai A, Pt S. Short course of low-dose steroids for management of delayed pericontusional edema after mild traumatic brain injury - A retrospective study. Surg Neurol Int. 2025 Jan 24;16:23. doi: 10.25259/SNI_948_2024. eCollection 2025. PMID 39926471
• Moll A, Lara M, Pomar J, Orozco M, Frontera G, Llompart-Pou JA, Moratinos L, Gonzalez V, Ibanez J, Perez-Barcena J. Effects of dexamethasone in traumatic brain injury patients with pericontusional vasogenic edema: A prospective-observational DTI-MRI study. Medicine (Baltimore). 2020 Oct 23;99(43):e22879. doi: 10.1097/MD.0000000000022879. PMID 33120830
• Hutchinson PJ, Jalloh I, Helmy A, et al. The management of brain edema in traumatic brain injury: state of the art and future directions. Nat Rev Neurol. 2020;16(5):293-306
• Venkatesh B, Hickey RW, McDonald JR. Role of corticosteroids in acute brain injury revisited. Crit Care Med. 2020;48(11):1633-1642
• Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B, Fernandes J, Gogichaisvili T, Golden N, Hartzenberg B, Husain M, Ulloa MI, Jerbi Z, Khamis H, Komolafe E, Laloe V, Lomas G, Ludwig S, Mazairac G, Munoz Sanchez Mde L, Nasi L, Olldashi F, Plunkett P, Roberts I, Sandercock P, Shakur H, Soler C, Stocker R, Svoboda P, Trenkler S, Venkataramana NK, Wasserberg J, Yates D, Yutthakasemsun PMID 15936423
• Cardona-Collazos S, Gonzalez WD, Pabon-Tsukamoto P, Gao GY, Younsi A, Paiva WS, Rubiano AM. Cerebral Edema in Traumatic Brain Injury. Biomedicines. 2025 Jul 15;13(7):1728. doi: 10.3390/biomedicines13071728. PMID 40722798
• Jha RM, Kochanek PM, Simard JM. Pathophysiology and treatment of cerebral edema in traumatic brain injury. Neuropharmacology. 2019 Feb;145(Pt B):230-246. doi: 10.1016/j.neuropharm.2018.08.004. Epub 2018 Aug 4. PMID 30086289

Identifiers

NCT: NCT07358312 · MF-2026-001 · MF-2026-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗