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TERMINATED
NCT01380028
PHASE3

Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2011-07-22

Completion Date

2014-09-12

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

oral corticosteroids

Active treatment is prednisone establishment within 72 hours after the end of surgery at the dose of 1 mg / kg (rounded to the nearest 10 mg) once daily orally for one week . The daily dose then decreases in increments of 10 mg weekly, by the second week. Once the level of 10 mg / day reached the daily dose by one level lower than 5 mg weekly. Treatment is stopped after this week to 5 mg / day (average 2 months of treatment)

DRUG

placebo

placebo

Locations (1)

Gui de Chauliac Hospital

Montpellier, France