Clinical trial NCT02111785: Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Official title: The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Subdural Hematoma
Keywords: Dexamethasone
Burr hole craniostomy
Chronic subdural hematoma
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms including headache, confusion, limb weakness, and difficulty speaking.

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: Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms including headache, confusion, limb weakness, and difficulty speaking.

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.

Eligibility criteria: Inclusion Criteria:

* Male or female subject aged 18 years of age or older
* 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:

* Presence of skull fracture over the subdural hematoma, or other specific etiology for cSDH not suitable for drainage by burr hole craniostomy, such as presence of a ventriculoperitoneal shunt
* 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

Primary outcomes:
measure: Number of Participants With a Modified Rankin Score of 0, 1 or 2
timeFrame: 6 months after diagnosis
Secondary outcomes:
measure: Rate of Treatment Failure
timeFrame: 6 months after diagnosis
measure: Participants With Modified Rankin Score 0, 1 or 2 at 6 Months
timeFrame: 6 months after hospital discharge
measure: Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up
timeFrame: 6 months after hospital discharge
measure: Participants With a Markwalder Grading Score of 0
timeFrame: 6 months after hospital discharge
Other outcomes:
measure: Rate of Radiographic Resolution of Chronic Subdural Hematoma
timeFrame: 6 months after diagnosis
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jennifer De Jong
role: STUDY_DIRECTOR
References: