Treatment of Chronic Subdural Hematoma by Corticosteroids
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Rennes University Hospital
- Enrollment
- 202
- Locations
- 17
- Primary Endpoint
- Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Methylprednisolone
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.
Intervention: Methylprednisolone (Drug)
Placebo
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Time Frame: 1 month
Secondary Outcomes
- Functional scales : cognitive(1, 3 and 6 months)
- Quality of life score(1, 3 and 6 months)
- Occurrence of adverse events potentially related to methylprednisolone(during the first 6 months)
- Survival(6 months)
- Radiological improvement(1, 3 and 6 months)
- Potassium(day 0, 7, 14, and 21 and 1 month)
- Fasting glucose(day 0, 7, 14, and 21 and 1 month)
- Rate of surgical treatment of the Chronic subdural hematomas(1, 3 and 6 months)
- Functional scales : daily living(1, 3 and 6 months)
- Plasma sodium(day 0, 7, 14, and 21 and 1 month)
- Time to surgical treatment(during the first 6 months)
- Functional scales : modified Rankin Scale(1, 3 and 6 months)