Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas (hemacort)
Chronic Intracranial Subdural Hematoma
About this trial
This is an interventional treatment trial for Chronic Intracranial Subdural Hematoma focused on measuring chronic subdural hematomas, corticosteroid, treatment, neurosurgery, recurrence, adjuvant
Eligibility 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,..)
Sites / Locations
- Gui de Chauliac Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
placebo
oral corticosteroids
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
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