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Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)

R

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

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

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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