Dexamethasone for the Treatment of Vasogenic Pericontusional Edema. (DEXCON-TBI)
Traumatic Brain Injury, Cerebral Edema
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic, brain, injury, contusion, edema, steroids
Eligibility Criteria
Inclusion Criteria:
- -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 Criteria:
- 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.
Sites / Locations
- Hospital Universitari Son EspasesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dexamethasone
Control
Dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). Dexamethasone (Fortecortin®) will be acquired from ERN, SA. Laboratories (Barcelona, Spain). The Son Espases Pharmacy Department will be in charge of developing and conditioning the 4mg, 2mg and 1mg dexamethasone / placebo capsules needed for 12 days of treatment, keeping the researchers blind
The preparation and conditioning of the capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS). The Son Espases Pharmacy Department will be responsible for identifying the containers and sending them by courier to the participating hospitals. A record of the dispensing of test samples will be kept and will be sent in acknowledgment of receipt for control