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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meditech Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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