TBI- Efficacy of Steroids in Acute Vasogenic Edema (TBI-SAVE)

January 13, 2026 updated by: Andres M. Rubiano, Meditech Foundation

Traumatic Brain Injury - Efficacy of Steroids in Acute Vasogenic Edema

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in the Hospital
Time Frame: Since the time of the injury, up to 3 months
Hospital Length of Stay, since the time of the injury, up to 3 months.
Since the time of the injury, up to 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms (blurred vision, headache, vomiting, dizziness, amnesia)
Time Frame: Since the injury, up to 3 weeks after the injury
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.
Since the injury, up to 3 weeks after the injury
Infections (surgical site infection, pneumonia, urinary tract infections, meningitis, bacteremia)
Time Frame: Since the second week of the injury, up to 1 month after the injury
Local or Systemic Infections, including surgical site infection, pneumonia, urinary tract infections, meningitis, and bacteremia. It will be recorded from the medical record.
Since the second week of the injury, up to 1 month after the injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meditech Foundation

Investigators

  • Principal Investigator: Andres M Rubiano, MD, PhD, Meditech Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF-2026-001 (Other Grant/Funding Number: Meditech Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On Request

IPD Sharing Time Frame

May 2029 - May 2034

IPD Sharing Access Criteria

Researchers and Scientists, by request, to the officers' emails.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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