TBI- Efficacy of Steroids in Acute Vasogenic Edema

NCT07358312 | Not Yet Recruiting DMC

• 1 other identifier: MF-2026-001
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Vasogenic Edema; Traumatic Brain Injury; Steroids; Brain Trauma

Outcome Measures

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).

  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 (1)

• Length of Stay in the Hospital

  Since the time of the injury, up to 3 months

Other Outcomes (2)

• Symptoms (blurred vision, headache, vomiting, dizziness, amnesia)

  Since the injury, up to 3 weeks after the injury

• Infections (surgical site infection, pneumonia, urinary tract infections, meningitis, bacteremia)

  Since the second week of the injury, up to 1 month after the injury

Study Arms (2)

Treatment Group

Patients with TBI and Dexamethasone Treatment after 5 days of Trauma

Control Group

Patients with TBI without Dexamethasone Treatment after 5 days of Trauma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meditech Foundation: lead

Related Publications (8)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• Venkatesh B, Hickey RW, McDonald JR. Role of corticosteroids in acute brain injury revisited. Crit Care Med. 2020;48(11):1633-1642

  BACKGROUND

• 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, Yutthakasemsunt S; CRASH trial collaborators. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet. 2005 Jun 4-10;365(9475):1957-9. doi: 10.1016/S0140-6736(05)66552-X.

  PMID: 15936423 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andres M Rubiano, MD, PhD

  Meditech Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy D Gonzalez, MD

CONTACT

+576023720672; gonzalez.wnedy.meditechf@outlook.com

Laura M Loaiza, MD

CONTACT

+576023720672; loaiza.laura.meditechf@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical and Research Director

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 2029 - May 2034
• Access Criteria: Researchers and Scientists, by request, to the officers' emails.