Evaluation of the effect and safety of atorvastatin and dexamethasone in the postoperative treatment of patients with chronic subdural hematoma.

Manuel Ascunce Domenech” University Hospital (HUMAD), in Camagüey0 个研究点目标入组 48 人开始时间: 2024年3月28日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

Manuel Ascunce Domenech” University Hospital (HUMAD), in Camagüey