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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Time frame: 1 month
Quality of life score
Short Form Health Survey 12 scale
Time frame: 1, 3 and 6 months
Time to surgical treatment
Time frame: during the first 6 months
Rate of surgical treatment of the Chronic subdural hematomas
Time frame: 1, 3 and 6 months
Functional scales : daily living
Instrumental Activities of Daily Living scale
Time frame: 1, 3 and 6 months
Functional scales : cognitive
Mini-Mental State Examination scale
Time frame: 1, 3 and 6 months
Functional scales : modified Rankin Scale
modified Rankin Scale
Time frame: 1, 3 and 6 months
Plasma sodium
Time frame: day 0, 7, 14, and 21 and 1 month
Potassium
Time frame: day 0, 7, 14, and 21 and 1 month
Fasting glucose
Time frame: day 0, 7, 14, and 21 and 1 month
Occurrence of adverse events potentially related to methylprednisolone
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CHU Bordeaux Neurochirurgie A
Bordeaux, France
CHU Bordeaux Neurochirurgie B
Bordeaux, France
CHU Brest
Brest, France
CHU Caen
Caen, France
CHU Lille
Lille, France
HC Lyon
Lyon, France
AP-HM - Hôpital La Timone
Marseille, France
...and 7 more locations
Time frame: during the first 6 months
Survival
Time frame: 6 months
Radiological improvement
Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated
Time frame: 1, 3 and 6 months