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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
EU CTIS ID: 2025-520887-17-00
What this study is testing
Efficacy of dexamethasone in improving the prognosis of patients with TBI, brain contusions and pericontusional edema.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Patients who have suffered a head injury and who present on computed tomography (CT) one or more bruises brain with pericontusion edema. Those patients will be included with bruises in which it was initially chosen medical, non-surgical treatment.
- - Age equal to or greater than 18 years and less than 85 years
- -Signature of the informed consent by the patient or his legal representative in case the patient cannot do so.
You likely can't join if
- - Patients with TBI and contusions who have required surgery Evacuation of brain contusion before randomization.
- - Patients with allergy or intolerance to the following excipients contents in dexamethasone/placebo capsules: lactose, starch corn or microcrystalline cellulose.
- - Patients with a history of psychotic disorders.
- - Patients unable to take oral medication due to swallowing problems and in which placing a nasogastric tube.
- - Patient with any systemic condition that, at the discretion of the investigator contraindicates the patient's inclusion in the study.
- Pregnant or breastfeeding patients.
See the full eligibility criteria
- - Patients who have suffered a head injury and who present on computed tomography (CT) one or more bruises brain with pericontusion edema. Those patients will be included with bruises in which it was initially chosen medical, non-surgical treatment.
- - Age equal to or greater than 18 years and less than 85 years
- -Signature of the informed consent by the patient or his legal representative in case the patient cannot do so.
- - Patients with TBI and contusions who have required surgery Evacuation of brain contusion before randomization.
- - Patients with allergy or intolerance to the following excipients contents in dexamethasone/placebo capsules: lactose, starch corn or microcrystalline cellulose.
- - Patients with a history of psychotic disorders.
- - Patients unable to take oral medication due to swallowing problems and in which placing a nasogastric tube.
- - Patient with any systemic condition that, at the discretion of the investigator contraindicates the patient's inclusion in the study.
- Pregnant or breastfeeding patients.
- - Patients with TBI who have required a craniotomy before randomization for any other reason: hematoma evacuation subdural, epidural or sinking fracture.
- - Patients in a 3-point GCS situation with bilateral mydriasis
- - Patients with an extracranial Injury Severity Score greater than 18 points.
- - Patients with associated spinal cord injuries.
- - Patients in whom the use of corticosteroids is contraindicated.
- - Patients who chronically take oral corticosteroids.
- - Patients included in another clinical trial.
- - Known intolerance or hypersensitivity to dexamethasone.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.