RATIONALE

Chronic subdural hematoma (CSDH) is a common neurological disease. The prevalence rises rapidly due to increasing age and widespread use of anticoagulants.

Burr hole craniostomy is the current standard practice. However, in several hospitals dexamethasone is used as a non-surgical alternative. Efficacy of dexamethasone has yet to be proven in high quality comparison studies.

Randomized controlled trials are necessary to evaluate the effect of dexamethasone therapy compared to surgery on functional outcome and cost-effectiveness.

OBJECTIVES

We hypothesize that treatment with dexamethasone is as effective as BHC, at lower costs.

Primary
Effect of dexamethasone therapy versus surgery in CSDH patients on

- Functional outcome, expressed by the modified Rankin Scale (mRS) at 3 months and
- Cost-effectiveness at 12 months

Secondary
- Functional outcome, expressed by the Glasgow Outcome Scale – Extended (GOS-E) at 3 months
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Functional outcome, expressed by the mRS and Markwalder Grading Scale (MGS) at 2 weeks, and at 3-, 6- and 12 months
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Failure of therapy within 12 months requiring intervention.
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Quality of life, as expressed by Short Form – 36 Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI) at 3 and 12 months
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Hematoma thickness at 2 weeks
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Recurrence of symptoms and hematoma during the first 12 months
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Complications during the first 3 months
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Mortality during the first 3 months
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Drug related adverse events
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Duration of hospital stay
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Health care and productivity costs at 3 and 12 months, measured with cost-effectiveness analysis (CEA) questionnaires

STUDY DESIGN

A prospective, multicenter, randomized controlled trial

Inclusion criteria
- Presence of a CSDH
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Severity of symptoms must be MGS 1-3
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Symptoms must correlate to the cerebral lesion
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Patient would be an eligible candidate for BHC (i.e. hematoma thickness ≥10mm)
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≥18 years

Exclusion criteria
- MGS 0 or MGS 4
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Acute subdural hematoma
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Minimal CSDH which is technically not drainable (i.e. hematoma thickness < 10 mm)
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Pregnancy
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Cerebrospinal fluid shunt in situ
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Known hypersensitivity to dexamethasone
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Known ulceration in the gastro-intestinal tract or history of gastro-intestinal bleeding
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Uncontrolled diabetes mellitus (DM), defined as a HbA1C value > 8% (64 mmol/mol)
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Clinical suspicion of a systemic infection (fever, leukocytosis, elevated C-reactive protein (CRP))
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Glaucoma
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Previous history of severe affective disorders on steroids (i.e. psychosis)

INTERVENTION

Patients are randomized to either initial treatment with dexamethasone or burr hole craniostomy.

Dexamethasone tapering course:
Day 1 - 4 2 x 8 mg
Day 5 -7 2 x 4 mg
Day 8 -10 2 x 2 mg
Day 11 -13 2 x 1 mg
Day 14 -16 2 x 0.5 mg
Day 17 -19 1 x 0.5 mg
Day 20 stop

With the addition of pantoprazol 1 x 40 mg on day 1 - 20.

If the response to dexamethasone is insufficient, surgery will be performed.