Atorvastatin and dexamethasone in adult patients with chronic subdural hematoma; Phase I-II.

Phase 1

• Conditions: Chronic subdural hematoma

• Registration Number: RPCEC00000436
• Lead Sponsor: Manuel Ascunce Domenech” University Hospital (HUMAD), in Camagüey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-15
• Results First Posted: 2026-11-30

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 48

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.