AuthorisedTherapeutic use (Phase IV)Interventional

Dexamethasone for the treatment of traumatic brain injured patients with brain contusions and pericontusional edema: Study protocol for a prospective, randomized and double blind trial

This research wants to find out if giving a common medicine called dexamethasone can help patients who have bruised brains and swelling after an injury. Doctors are comparing it to a dummy pill, known as a placebo, to see if dexamethasone helps improve how well people recover. They will carefully check the patients' progress one month after their injury using a special scale to measure their recovery. This study aims to understand if dexamethasone is an effective treatment for this type of brain injury, hopefully leading to better care for patients in the future.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

University Hospital Son Espases

Enrolment target

Start

26 Mar 2026

Post-traumatic brain contusion with edema

What is this study about?

When someone has a head injury, they can sometimes get bruises on their brain, known as contusions. These bruises can cause swelling around them, called oedema. This swelling can put pressure on the brain and make recovery more difficult. Doctors are always looking for better ways to help people heal from these serious injuries.

This study is testing a medicine called dexamethasone. Dexamethasone is a type of steroid medicine that is often used to reduce swelling in different parts of the body. Here, doctors want to see if it can specifically help reduce the swelling around brain bruises after an injury and improve how well people recover.

To find out if dexamethasone really works, some patients will receive the actual medicine, while others will get a placebo. A placebo looks exactly like the real medicine but contains no active ingredients. This 'blinded' approach helps researchers get a clear and unbiased answer about the medicine's effects. The main goal is to see if patients who received dexamethasone show better recovery one month after their injury compared to those who received the placebo.

Key takeaways

This study investigates if dexamethasone helps recovery after a traumatic brain injury with swelling.
Patients will receive either dexamethasone or a dummy pill (placebo).
It's a 'double-blind' study, meaning no one knows who gets which treatment.
Researchers will check recovery one month after the injury.
All adults aged 18 and over with specific brain injuries can be considered.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit, so people of any adult age can potentially take part.

Both men and women are welcome to participate in this research. The study needs people who have had a head injury that has caused a bruise on their brain and swelling around it. This is called a post-traumatic brain contusion with oedema.

Since this is general information, if you think you or a loved one might be suitable, it's really important to talk to your doctor. They will have all the detailed information about who can and cannot join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a head injury that caused a bruise on your brain?
Is there swelling (oedema) around the bruise on your brain?
Are you able to follow study instructions and attend follow-up assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the study medicine (dexamethasone) or a dummy pill (placebo) as part of your treatment. Both you and your doctors wouldn't know which one you are receiving – this is called a 'double-blind' study and helps make the results fairer.

Your usual medical care for your brain injury would continue. Doctors would regularly check your progress and overall health, especially during the first month after your injury. They would use standard medical tests and observations, including a specific scale called the 'Extended Glasgow Outcome Scale (GOSE)', to measure your recovery. The total duration of your active participation, especially for measuring the main outcome, would be around one month from your injury. There might be some follow-up checks after this, but the most intensive part would be within that first month.

Potential risks and benefits

Taking part in a study like this might offer a chance to receive a treatment that could potentially help your recovery from a brain injury, although there's no guarantee the study medicine will be more effective than standard care. You might also be contributing to important medical knowledge that could help future patients. Like all medicines, dexamethasone can have side effects, and your doctors would monitor you closely for any. There's also the chance you might receive the placebo. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is dexamethasone?

Dexamethasone is a type of steroid medicine often used to reduce swelling and inflammation in the body.

What is a brain contusion?

A brain contusion is like a bruise on the brain that can happen after a head injury.

What does 'placebo' mean?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.

Will I know if I'm getting dexamethasone or the placebo?

No, neither you nor your doctors will know if you are receiving dexamethasone or the placebo during the study. This is normal for this type of research.

How long will the study last for me?

The main part of monitoring your progress for the study's goal will be about one month after your brain injury.