Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Collaborators: Centre hospitalier de Perpignan; Centre Hospitalier Universitaire de Nice; Hospices Civils de Lyon; University Hospital, Marseille
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Patients of both sexes operated for chronic subdural hematoma one-sided or bilateral of firstly diagnosis, after consultation in neurosurgery for a symptomatology in touch with this hematic collection.

• At the End of the surgical operation < 72 hours

• Hematoma must be hypodense or isodense. He has to present a value < 50 on the scale of Hounsfield measured in the center of the collection on the initial intellectual scanning, this measure not in front of not to be made on a zone of new bleeding treble or on a membrane (in case of compartmentalized hematoma).

The blade of the hematoma has to measure at least 3 mm in thickness on an axial cutting.

Exclusion Criteria:

• Age < 18 years

• Weight > 104 kg

• Histories of hematoma chronic subdural for which a medical and\or surgical treatment were before realized

• Patient Presenting:

uncontrolled arterial hypertension, current Infection, Diabetes treated by drugs, Ulcer evolutionary gastroduodenal in the course of treatment and dating < 6 months, turned out Osteoporosis symptomatic of cortisone origin, uncontrolled psychotic State by a treatment, except the sultopride, ulcerous Colitis, recent intestinal Anastomose, Renal insufficiency, hepatic Incapacity, Hypercalcemia,Hypercalciuria,calcic Lithiasis, high sensibility at drug'study, Intolerance: galactose, fructose, deficit in lactase, syndrome of malabsorption of glucose or galactose

• Clinical or radiological Characteristics of hematoma suspecting an intra-cranial infection (abscess,..)