Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

Phase 2

Terminated

Conditions: Chronic Subdural Hematoma

Interventions: Procedure: Burr Hole Craniostomy
Drug: Dexamethasone

Registration Number: NCT02111785

Lead Sponsor: University of Virginia

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Burr Hole Craniostomy randomized	Burr Hole Craniostomy	Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
Burr hole craniostomy observational	Burr Hole Craniostomy	Observational cohort of patients selecting burr hole craniostomy
Dexamethasone observational	Dexamethasone	Observational cohort of patients treated with dexamethasone protocol
Dexamethasone randomized	Dexamethasone	Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Modified Rankin Score of 0, 1 or 2	6 months after diagnosis	The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead. Higher scores on the mRS scale mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Rate of Treatment Failure	6 months after diagnosis	This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group
Participants With Modified Rankin Score 0, 1 or 2 at 6 Months	6 months after hospital discharge	The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead. Higher scores on the mRS scale mean a worse outcome.
Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up	6 months after hospital discharge	Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome.
Participants With a Markwalder Grading Score of 0	6 months after hospital discharge	Markwalder Grading Score (MGS) The MGS is assessed as follows: Grade 0 - Patient neurologically normal Grade 1 - Patient alert and oriented; mild symptoms, such as headache; absent or mild symptoms or neurologic deficit, such as reflex asymmetry Grade 2 - Patient drowsy or disoriented with variable neurological deficit, such as hemiparesis Grade 3 - Patient stuporous but responding appropriately to noxious stimuli; several focal signs, such as hemiparesis Grade 4 - Patient comatose with absent motor response to painful stimuli; decerebrate or decorticate posturing. Higher scores mean a worse outcome.