Clinical Trial: Treatment of Chronic Subdural Hematoma by Corticosteroids

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Chronic Subdural Hematoma by Corticosteroids

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 Summary:

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.

Sponsor: Rennes University Hospital

Current Primary Outcome: Delay of occurrence of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 1, 3 and 6 months ]
    Short Form Health Survey 12 scale
  • 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 [ Time Frame: 1, 3 and 6 months ]
    Instrumental Activities of Daily Living scale
  • Functional scales : cognitive [ Time Frame: 1, 3 and 6 months ]
    Mini-Mental State Examination scale
  • Functional scales : modified Rankin Scale [ Time Frame: 1, 3 and 6 months ]
    modified Rankin Scale
  • 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 [ Time Frame: during the first 6 months ]
  • Survival [ Time Frame: 6 months ]
  • Radiological improvement [ Time Frame: 1, 3 and 6 months ]
    Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated


Original Secondary Outcome: Same as current

Information By: Rennes University Hospital

Dates:
Date Received: January 4, 2016
Date Started: June 2016
Date Completion: June 2019
Last Updated: September 5, 2016
Last Verified: December 2015