Chronic Subdural Hematomas
Conditions
Keywords
chronic subdural hematomas, surgical treatment, corticosteroids
Brief 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.
Detailed description
The primary objective is to evaluate the efficacy of corticosteroids treatment in patients with Chronic subdural hematomas without clinical or radiological signs of severity. Secondary objectives are to assess the effect of methylprednisolone on: * quality of life evolution, * morbidity and mortality, * radiological evolution of the lesions.
Interventions
DRUGMethylprednisolone
DRUGPlacebo
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delay of occurrence of surgical treatment of the Chronic subdural hematomas | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to surgical treatment | during the first 6 months | — |
| Rate of surgical treatment of the Chronic subdural hematomas | 1, 3 and 6 months | — |
| Functional scales : daily living | 1, 3 and 6 months | Instrumental Activities of Daily Living scale |
| Functional scales : cognitive | 1, 3 and 6 months | Mini-Mental State Examination scale |
| Functional scales : modified Rankin Scale | 1, 3 and 6 months | modified Rankin Scale |
| Quality of life score | 1, 3 and 6 months | Short Form Health Survey 12 scale |
| Potassium | day 0, 7, 14, and 21 and 1 month | — |
| Fasting glucose | day 0, 7, 14, and 21 and 1 month | — |
| Occurrence of adverse events potentially related to methylprednisolone | during the first 6 months | — |
| Survival | 6 months | — |
| Radiological improvement | 1, 3 and 6 months | Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated |
| Plasma sodium | day 0, 7, 14, and 21 and 1 month | — |
Countries
France
Outcome results
None listed