Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Chronic Subdural Hematomas

Treatments: Drug: Placebo; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02650609

2015-000927-96

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups, including a placebo group

Methylprednisolone

Experimental group

Description:

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.

Treatment:

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo