Traumatic Brain InjuryTBI-SAVENCT07358312
TBI- Efficacy of Steroids in Acute Vasogenic Edema
An observational study of Traumatic Brain Injury, run by Meditech Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Vasogenic Edema, Traumatic Brain Injury, Steroids, Brain Trauma
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Hospital Length of Stay, since the time of the injury, up to 3 months.
Measured: Since the time of the injury, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meditech Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Rubiano, Meditech Foundation
- Investigators
- Andres M Rubiano, MD, PhD, Principal investigator, Meditech Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358312
- Sponsor's protocol ID
- MF-2026-001
- Other IDs
- MF-2026-001
- Acronym
- TBI-SAVE
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On Request
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.
PubMed 39926471Moll 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.
PubMed 33120830Hutchinson 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, 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.
PubMed 15936423Cardona-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.
PubMed 40722798Jha 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.
PubMed 30086289
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury - Efficacy of Steroids in Acute Vasogenic Edema
- ClinicalTrials.gov ID
- NCT07358312
- Acronym / sponsor ID
- TBI-SAVE / MF-2026-001
- Conditions
- Traumatic Brain Injury
- Keywords
- Vasogenic Edema, Traumatic Brain Injury, Steroids, Brain Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Meditech FoundationUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Length of Stay in the Hospital
Time frame: Since the time of the injury, up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- BackgroundPérez-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: PubMed 39926471Prasad 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.
- Background: PubMed 33120830Moll 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.
- BackgroundHutchinson 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
- BackgroundVenkatesh B, Hickey RW, McDonald JR. Role of corticosteroids in acute brain injury revisited. Crit Care Med. 2020;48(11):1633-1642
- Background: PubMed 15936423Edwards 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.
- Background: PubMed 40722798Cardona-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.
- Background: PubMed 30086289Jha 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.
- Individual participant dataSharing planned: Yes. On Request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andres M Rubiano, MD, PhD principal investigator
Meditech Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Meditech Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy D Gonzalez, MD (+576023720672, gonzalez.wnedy.meditechf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358312, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.