Treatment of chronic subdural hematoma by corticosteroids : a prospective randomized study
- Conditions
- chronic subdural hematomaMedDRA version: 18.0 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-000927-96-FR
- Lead Sponsor
- CHU of Rennes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 226
-Age = 18 years old
-With chronic or subacute, uni- or bilateral subdural hematoma
-Confirmed by cerebral CT scan without contrast enhancement
-Without clinical and radiological signs of severity
-Written informed consent from patients or thier next of kin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Contraindication for methylprednisolone
-Previous surgery for chronic subdural hematoma during the past 6 months
-Pre-existing severe dementia
-Existing neurological pathology that can be associated with dementia
-Patients treated with corticosteroids
-Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: show that a treatment with methylprednisolone can decrease the need for surgical treatment in patients with chronic subdural hematoma without clinical or radiological signs of severity;<br> Secondary Objective: assess the effect of methylprednisolone on :<br> -quality of life evolution<br> -morbidity and mortality<br> -radiological evolution of the lesions<br> ;Primary end point(s): rate of surgical treatment of the chronic subdural hematoma;Timepoint(s) of evaluation of this end point: at one month
- Secondary Outcome Measures
Name Time Method