Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Montpellier
Collaborators:
Centre hospitalier de Perpignan Centre Hospitalier Universitaire de Nice Hospices Civils de Lyon University Hospital, Marseille