Treatment of Chronic Subdural Hematoma by Corticosteroids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Chronic Subdural Hematoma by Corticosteroids

Conditions
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Chronic Subdural Hematomas

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>Methylprednisolone will be supplied as powder and stored in capsules containing 16 mg with lactose as excipient. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg): <60 kg: 3 pills of 16 mg/day 60-80kg: 4 pills of 16 mg/day >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. | Drug: Methylprednisolone<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules will only contain lactose. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg): <60 kg: 3 pills of 16 mg/day 60-80kg: 4 pills of 16 mg/day >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of occurrence of surgical treatment of the Chronic subdural hematomas |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | Short Form Health Survey 12 scale | 1, 3 and 6 months | 
| 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 | Instrumental Activities of Daily Living scale | 1, 3 and 6 months | 
| Functional scales : cognitive | Mini-Mental State Examination scale | 1, 3 and 6 months | 
| Functional scales : modified Rankin Scale | modified Rankin Scale | 1, 3 and 6 months | 
| Plasma sodium |  | day 0, 7, 14, and 21 and 1 month | 
| 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 | Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic subdural hematomas, surgical treatment, corticosteroids