Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
NCT ID: NCT02111785
Last Updated: 2018-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2014-03-31
2017-12-31
Brief Summary
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There is currently no agreement among physicians as to the best way to treat this condition.
The study hypothesis to be tested was: For patients with unilateral, symptomatic chronic subdural hematoma, there is no difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2 at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with those treated with burr hole surgical drainage.
Detailed Description
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There is currently no agreement among physicians as to the best way to treat this condition. One option is to do a surgery to drain the blood that has collected. Usually the surgery involves drilling small holes in the skull to relieve pressure and allow blood and fluids to be drained. Another option is to give medications such as steroids that might reduce the swelling. However, no drugs have been approved by the Food and Drug Administration (FDA) specifically to treat this condition. Some patients elect to have no treatment.
The purpose of this study was to investigate whether investigational treatment with a 2 week course of oral dexamethasone is as effective as surgery for cSDH. The study hypothesis to be tested was: For patients with unilateral, symptomatic chronic subdural hematoma, there is no difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2 at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with those treated with burr hole surgical drainage.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Burr Hole Craniostomy randomized
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Dexamethasone randomized
Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
Dexamethasone
Treatment with a short course of oral dexamethasone
Burr hole craniostomy observational
Observational cohort of patients selecting burr hole craniostomy
Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Dexamethasone observational
Observational cohort of patients treated with dexamethasone protocol
Dexamethasone
Treatment with a short course of oral dexamethasone
Interventions
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Dexamethasone
Treatment with a short course of oral dexamethasone
Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent obtained from a patient or a legal representative before enrollment
* Enrollment into the study within 12 hours of detection of chronic subdural hematoma on cranial imaging
* Presence of symptoms referable to chronic subdural hematoma, including one or more of the following: Headache; altered mental status, limb weakness, dysphasia, or focal neurological deficit
* Demonstration of unilateral chronic subdural hematoma on cranial imaging, including the following features: On computed tomography imaging, iso- or hypo-intensity extra-axial collection with or without presence of acute component; radiologic interpretation of magnetic resonance imaging consistent with subacute or chronic SDH; with or without evidence of acute hemorrhagic component
* Maximum depth of subdural hematoma of less than 20mm, with less than 10mm of midline shift, as measured on axial CT or MR imaging
* Absence of skull fracture over the subdural hematoma
* Able to receive the drug treatment
Exclusion Criteria
* Extent of subdural hematoma \> 20mm in maximal depth, or \> 10mm of midline shift, as measured on axial CT or MR imaging
* GCS \<8 or cSDH of an extent or size for which craniotomy, rather than burr hole drainage alone, is judged necessary by the neurosurgery attending on call
* Prior diagnosis of dementia
* Presence of symptomatic peptic ulcer, psychosis, active or suspected TB, acute infection, or documented hypersensitivity or allergy to dexamethasone
* Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Principal Investigators
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Jennifer De Jong
Role: STUDY_DIRECTOR
University of Virginia
Locations
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University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17294
Identifier Type: -
Identifier Source: org_study_id