Clinical Trial: Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas. Prospective Randomized Multicenter Trial

Brief Summary: The chronic subdural hematoma is a common disease in the population over 60 years. For example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A chronic subdural hematoma is an accumulation of blood in the intracranial space between brain membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain injury, which causes the rupture of small vessels in the area. During its evolution, the volume of the hematoma increases. After a few weeks, the amount of fluid build-up can compress the brain. That's when clinical symptoms occur: persistent headaches, neurological deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired intellectual function, or hallucinations, etc.). The compression of the brain may cause impairment of consciousness resulting in more severe cases coma and death. At this stage, a neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over six months after neurosurgery). That is why in France, about 20% of medical teams administer a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now, the potential benefit of this treatment has not yet been confirmed by a clinical study. So the purpose of this research.

Detailed Summary: The chronic subdural hematoma (HSDC) is a common disease in the population over 60 years. The incidence is 7 / 100000 in patients over 70 years. This condition occurs readily after a minor head injury. Bleeding secondary to cerebral concussion and vascular fragility from a cortico-dural vein. It is favored in most cases by taking anti-platelet or other blood thinners. The hematoma formed and causes a local inflammatory reaction. This reaction tends to partition the collection by the formation of a membrane whose pathological vessels weakened by inflammation, causing bleeding iterative low abundance. A vicious circle is established by a combination of these phenomena and causes a progressive worsening clinical and radiological.Because of the importance of recurrence (15 to 25% at 6 months) and the high rate of mortality at one year (10 to 15%), but also supposed pathophysiological mechanisms (inflammation, formation of membrane self-sustaining blood collection ), a postoperative treatment with corticosteroids was introduced in secondary prevention by some teams (about 20% in France). However, this practice has never been a prospective study on clinical and radiological interest.The aim of this prospective multicenter randomized, double blind, is to evaluate in patients with chronic subdural hematoma, compared with placebo, the efficacy of postoperative corticosteroid treatment orally for approximately 2 months on the rate of clinical recurrence and / or radiological subdural hematoma 6 months after surgery (primary endpoint).The secondary endpoints are the rate of mortality at one year, and the 6 month follow-up of clinical and radiological evolution, neurological status (Markwalder scale), quality of life (health scale perceptual Nottingham), autonomy (Karnofsky scale), the state of consciousness (Glasgow scale), and size of the hematoma on CT scan without injection.340 adult patients of the 2 sexes who received surgical treatment for a chronic subdural hematoma uni
Sponsor: University Hospital, Montpellier

Current Primary Outcome: the evaluation of efficacy of postoperative corticosteroid treatment in patients group compared with placebo [ Time Frame: 6 months after surgery ]

The objective of this study is to evaluate in patients with chronic subdural hematoma, compared with placebo, the efficacy of postoperative corticosteroid treatment orally for about two months on the rate of clinical recurrence and / radiological or subdural hematoma 6 months after surgery (primary endpoint).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of mortality rate at one year [ Time Frame: one year ]
    Secondary objective is the evaluation of the effectiveness of corticosteroid treatment on the postoperative mortality rate at one year
  • Evaluation of quality of life at one year [ Time Frame: one year ]
    Secondary objective is the evaluation of the effectiveness of corticosteroid treatment on the quality of life of patients
  • evaluation of tolerance at one year [ Time Frame: one year ]
    Secondary objective is the evaluation of the tolerance of corticosteroid treatment at one year.


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: June 16, 2011
Date Started: September 2010
Date Completion: December 2016
Last Updated: July 22, 2015
Last Verified: July 2015