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Study of dexamethasone for the treatment of brain bruising and swelling in patients with traumatic brain injury

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the use of dexamethasone to help patients suffering from traumatic brain injury. This condition occurs when a sudden blow or impact to the head causes damage to the brain. Specifically, the research focuses on individuals with brain contusion, which is a bruise on the brain tissue, and pericontusional edema, which refers to swelling in the area surrounding the bruised part of the brain.

The purpose of the study is to evaluate how well the medication works to improve the recovery of patients with these injuries. Participants will be assigned to receive either dexamethasone or a placebo. During the course of the study, the treatment will be administered orally in the form of tablets.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation and treatment
After joining the study, a treatment is assigned to address brain contusions (bruising of the brain) and pericontusional edema (swelling around the bruised area of the brain).
One of two options is provided: either the test medication, which is dexamethasone (a type of steroid used to reduce swelling), or a placebo (a pill containing no active medicine, such as microcrystalline cellulose and riboflavin, used for comparison).
If the dexamethasone is assigned, a dose of 16 mg is administered orally using tablets.
Step 2
Follow-up and evaluation
One month after the initial injury, the outcome is evaluated using the extended glasgow outcome scale (gose). this is a tool used to measure the level of recovery and functional ability following a brain injury.

Who can join the trial?

5 criteria

You must have suffered a head injury that shows one or more bruises on the brain (contusions) on a computed tomography (CT) scan, which is a special type of X-ray used to see inside the body.
You must have swelling in the brain tissue (pericontusional edema) surrounding the bruised areas.
The medical team must have decided that your condition can be managed with non-surgical treatment (medicine or other therapies that do not require an operation) rather than surgery.
You must be at least 18 years old and under 85 years old.
You or your legal representative (someone legally authorized to make decisions for you) must sign an informed consent form, which is a document that explains the study details before you agree to join.

Who cannot join the trial?

14 criteria

Patients who have had surgery to remove damaged brain tissue (called evacuation of brain contusion) before being assigned to a study group.
Patients who are allergic or have a bad reaction to ingredients like lactose, corn starch, or microcrystalline cellulose (inactive substances used to make up the capsule).
Patients who have a history of psychotic disorders, which are serious mental health conditions that affect a person's ability to think clearly or perceive reality.
Patients who cannot swallow pills and cannot have a nasogastric tube (a thin tube passed through the nose into the stomach) inserted to provide medicine.
Patients with any general health condition that the investigator (the main doctor in charge of the study) decides makes it unsafe to participate.
Patients who are pregnant or currently breastfeeding.
Patients who have had a craniotomy (a surgery where a piece of the skull is removed to access the brain) to treat a hematoma (a collection of blood outside of blood vessels), a subdural or epidural bleed, or a sinking fracture (a type of broken skull bone) before starting the study.
Patients with a low GCS score (a tool used to measure a person's level of consciousness) of 3 points combined with bilateral mydriasis (when both pupils of the eyes are abnormally large and do not react to light).
Patients with an extracranial Injury Severity Score higher than 18 points, which is a measurement used to grade the seriousness of injuries located outside of the skull.
Patients who have sustained injuries to the spinal cord (the bundle of nerves that runs down the back and carries messages between the brain and body).
Patients who are medically advised not to use corticosteroids (a type of steroid medicine used to reduce inflammation).
Patients who regularly take oral corticosteroids (steroid medicine taken by mouth) on a long-term basis.
Patients who are already participating in a different clinical trial (a research study involving human participants).
Patients who have a known hypersensitivity (an extreme allergic reaction) to dexamethasone (the specific steroid medicine being studied).

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Investigated drugs

Dexamethasone is a type of steroid medication used in this study to help reduce swelling and inflammation in the brain for patients who have suffered a brain injury.

Dexamethasone

What is already known about the treatment

Dexamethasone - This medication is taken by mouth in the form of a tablet. It is a well-established medicine used widely in clinical practice to reduce swelling and inflammation in various parts of the body. At a molecular level, it works by mimicking natural hormones to turn off the body's inflammatory response, which helps decrease pressure and swelling in the brain. It belongs to a class of drugs known as corticosteroids.

Investigated diseases

Post-traumatic brain contusion with edema - This condition occurs when a physical injury to the head causes bruising on the brain tissue. The injury leads to localized bleeding and damage to the small blood vessels within the brain. Following the bruising, fluid begins to accumulate in the injured area, causing the brain tissue to swell. This swelling creates extra pressure around the site of the injury. As the process continues, the inflammation and fluid buildup can affect the surrounding brain structures.