Effect of dexamethasone (DXM) therapy in patients with a brain bleed: A comparision of a non-operative treatment versus surgery on patient recovery.
- Conditions
- Chronic subdural hematoma.MedDRA version: 18.1Level: LLTClassification code 10049163Term: Chronic subdural hematomaSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-001563-39-NL
- Lead Sponsor
- Medical Centre Haaglanden (MCH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Presence of a chronic subdural hematoma: An isodens or hypodens hematoma on cranial CT-scan. Hyperdens components may be present but must compromise less than 1/3 of the hematoma.
- Clinical symptoms must correlate to the cerebral lesion.
- Severity of symptoms must be Marwalder Grading Score 1-3.
- Subject must be 18 years or older.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- An acute subdural haematoma.
- Pregnancy.
- Known hypersensitivity to DXM.
- Known ulceration in the gastro-intestinal tract.
- Uncontrolled diabetes mellitus (DM).
- Clinical suspicion of an acute systemic infection (fever, leucocytosis, elevated C-reactive protein (CRP)).
- History of gastro-intestinal bleeding.
- Glaucoma.
- Previous history of severe affective disorders on steroids (i.e. psychosis).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method