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Brain injury study tests steroid treatment for swelling

NCT ID NCT07358312

Knowledge-focused Sponsor: Meditech Foundation Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a steroid called dexamethasone can improve recovery in people with traumatic brain injury who develop brain swelling. Researchers will follow 280 adults aged 18 to 70 who already receive this treatment as part of their care, comparing their outcomes to similar patients who do not get the drug. The main goal is to see if the steroid leads to better function one month after the injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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