Treatment of Chronic Subdural Hematoma by Corticosteroids

• Status: Completed
• Trial end date: 2020-03-20
• Target enrollment: 0
• Participant gender: All

Summary

Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age 18 years old,

• With chronic or subacute, uni or bilateral subdural hematoma,

• Confirmed by cerebral scan without contrast enhancement,

• Without clinical and radiological signs of severity,

• Written informed consent from patients or their next of kin according to the patients cognitive status.

Exclusion Criteria:

• Diabetics patients,

• Contraindication for methylprednisolone,

• Previous surgery for chronic subdural hematoma during the past 6 months,

• Pre-existing severe dementia related to other etiology than the Chronic subdural hematomas,

• Existing neurological pathology that can be associated with dementia,

• Patients treated with corticosteroids,

• Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),

• Participating in other concomitant research.