Status:
UNKNOWN
Dexamethasone for the Treatment of Vasogenic Pericontusional Edema.
Lead Sponsor:
Hospital Son Espases
Conditions:
Traumatic Brain Injury
Cerebral Edema
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients wit...
Eligibility Criteria
Inclusion
- -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
- 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.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04303065
Start Date
July 24 2020
End Date
February 1 2024
Last Update
November 23 2020
Active Locations (1)
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1
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120