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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Servei De Salut De Les Illes Balears Palma Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
15.01.2019

Trial locations

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.

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.

Trial ID:
2025-520887-17-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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