Chronic subdural hematoma
Conditions
Interventions
Group I - Atorvastatin (Experimental): Atorvastatin and, Conventional treatment. The atorvastatin will be administered 20 mg daily orally for 8 weeks, starting on the first postoperative day. The Conv
from day 4 to 6, one vial (4 mg) every 8 hours intravenously
on day 7, one vial (4 mg) every 12 hours intravenously
From day 8 to 10, one tablet (4mg) will be administered orally every 12 hours
and from day 11, one tablet (4 mg) will be administered orally daily until the treatment is completed. The Conventional treatment will be administered in the same way of the group IV.
Group III - Ator
Atorvastatin
Dexamethasone
Tablets
Administration, Oral
Administration, Intravenous
Sponsors
“Manuel Ascunce Domenech” University Hospital (HUMAD), in Camagüey
Ministry of Public Health, Cuba.
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Compliance with the diagnostic criteria (tomographic of a chronic subdural hematoma, visualized as an extra-axial collection, in the shape of a crescent that extends over the surface of one or both cerebral hemispheres, independent of the density and its characteristics. morphological, causing displacement of midline structures or collapse of the ventricular system, with criteria for surgical treatment, regardless of the technique selected). 2. Age between 19 and 80 years. 3. Voluntariness of the patient (or family member) through the granting of informed (oral) consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are on artificial mechanical ventilation at the time of diagnosis. 2. Patients who do not recover in the immediate postoperative period and are maintained on artificial mechanical ventilation. 3. Known hypersensitivity to atorvastatin or steroids. 4. Patients treated with any of the drugs under study in the four weeks prior to inclusion in the study. 5. Patients under treatment with anticoagulants or with a coagulation disorder. 6. Patients included in other clinical trials. 7. Severe and uncontrolled arterial hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) that does not decrease after treatment. 8. Pregnancy or lactation at the time of inclusion in the study (referred by the patient or family member). 9. Obvious mental inability to give consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in the volume of the subdural hematoma (It will be evaluated as “Yes” when the volume in mL of the current Computed Axial Tomography decreases with respect to the initial evaluation and “No” in any other case). Measurement time: At baseline, at the 7th day and at the month. 2. Reduction in recurrences of subdural hematoma (by Computerized Axial Tomography; Yes, No). Measurement time: At baseline, at the 7th day and, at a month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visualization of the membranes (Yes, No). Measurement time: At baseline, at the 7th day and at the month. 2. Collection index (numerical value). Measurement time: At a month and at 4 months. 3. Decrease in the rate of reinterventions (Yes, No). Measurement time: At a month and 4 months. 4. Reduction in operative morbidity (Yes, No). Measurement time: upon hospital discharge. 5. Survival (alive, dead). Measurement time: At hospital discharge and, At a month and 4 months. 6. Clinical prognosis (according to the Glasgow outcome assessment scale: 1) favorable (good recovery, if the patient returns to his pre-trauma activities free of sequelae or with minimal sequelae; moderate disability, if sequelae that do not allow the patient to reintegrate to his previous activity, but allow him an independent life); 2) unfavorable (severe disability, if the patient requires the assistance of another person for care; vegetative state or death)). Measurement time: At hospital discharge and, At a month and 4 months. 7. Clinical Adverse Events (AEs). They will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, serious), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, Worsening, Death caused by this event). Measurement time: daily during hospital admission and, At a month and 4 months. 8. Laboratory (numerical values of hematological and blood chemistry tests: blood count, hematocrit, leukogram with differential, platelet count, coagulogram, bleeding time, prothrombin time, coagulation time, blood gases, ALAT, ASAT, blood glucose, creatinine, lipidrogram, inogram, among others). Measu | — |
Countries
Cuba
Contacts
Public ContactGretel Mosquera Betancourt
“Manuel Ascunce Domenech” University Hospital (HUMAD)
Outcome results
None listed