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Steroid trial for brain injury halted early

NCT ID NCT04303065

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 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

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

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: * -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.

brain edema Brain Injuries, Traumatic Contusions Edema head injury injury traumatic brain injury

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.