Chronic subdural hematoma. MedDRA version: 18.1 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Dexamethasone (generic: i.e. Apotex, Centrafarm, Teva)
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration
Sponsors
Medical Centre Haaglanden (MCH)
Medical Centre Haaglanden (MCH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of initial dexamethasone therapy compared to primary surgery on functional outcome (as expressed by the modified Rankin Score, mRS) in patients with a chronic subdural hematoma after 3 months.;Primary end point(s): The functional outcome (as expressed by the modified Rankin Scale, mRS) in patients with a chronic subdural hematoma.;Timepoint(s) of evaluation of this end point: After 3 months.;Secondary Objective: To compare other variables in both subject groups (dexamethasone versus surgery), such as: - Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS). - Number of surgical intervention prevented in intervention (DXM) group. - Quality of life (as expressed by Short Form (36) Health Survey, at 6 months). - Haematoma thickness (after 2 weeks). - Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months). - Complications (during hospital stay and DXM therapy). - Mortality (within the first 3 months). - Drug related adverse events. - Duration of hospital stay. - Costs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objectives: - Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS). - Number of surgical intervention prevented in intervention (DXM) group. - Quality of life (as expressed by Short Form (36) Health Survey, at 6 months). - Haematoma thickness (after 2 weeks). - Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months). - Complications (during hospital stay and DXM therapy). - Mortality (within the first 3 months). - Drug related adverse events. - Duration of hospital stay. - Costs. ;Timepoint(s) of evaluation of this end point: As specified in E5.2 | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Neurosurgery
Medical Centre Haaglanden (MCH)
Outcome results
None listed