Steroid trial for brain injury halted early
NCT ID NCT04303065
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if the steroid dexamethasone could help people with traumatic brain injury who had brain contusions and swelling. It planned to enroll 600 adults, giving them a short course of dexamethasone or a placebo. The main goal was to measure recovery using the Glasgow Outcome Scale at one and six months. However, the trial was terminated early, so no conclusions could be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexamethasone (a steroid anti-inflammatory drug)
- What this could lead to
- If it had succeeded, this could have pointed toward a treatment to reduce brain swelling and improve recovery after head injury.
- What could go wrong
- The trial was terminated, so results are not available. Steroids can have side effects like infection risk, and earlier studies have shown mixed results for brain 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.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
600 people
The number who actually took part.
- Started
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Jul 2020
- Finished
-
Dec 2025
- 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.
- Ages
-
18 to 85 years
- Sex
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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 Hide 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: * -Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan. * Patients with brain contusions in whom non-sugical treatment has been selected initially. * Age 18 or over and under 85 * Signing of informed consent by the patient or by his legal representative. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use dexamethasone in a particular patient with TBI. This pragmatic approach will allow us to see whether the intervention improves patient outcomes under real-life conditions. Exclusion Criteria: * Patients with TBI and brain contusions who have required surgery to evacuate the cerebral contusion before randomization. * Patients with TBI who have required a craniotomy before randomization for any other reason: evacuation of subdural, epidural hematoma or depressed skull fracture. * Patients with an extracranial Injury Severity Score greater than 18 points. * Patients in whom the use of corticosteroids is contraindicated. * Patients who take oral corticosteroids chronically. * Patients included in another clinical trial. * Known intolerance or hypersensitivity to dexamethasone. * Patients with allergy or intolerance to the following excipients contained in dexamethasone / placebo capsules: lactose, corn starch or microcrystalline cellulose. * Patients with a history of psychotic disorders. * Patients with inability to take medication orally due to swallowing problems in which it is not indicated to place a nasogastric tube. * Pregnant or breastfeeding patients. * Patients in a GCS 3 points situation with bilateral dilated pupils. * Patients with associated spinal cord injuries. * Patient with any systemic condition that contraindicates the use of corticosteroids.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury