Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)

University of Virginia

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Chronic Subdural Hematoma

Treatments: Drug: Dexamethasone; Procedure: Burr Hole Craniostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02111785

17294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 4 patient groups

Burr Hole Craniostomy randomized

Active Comparator group

Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Treatment:

Procedure: Burr Hole Craniostomy

Dexamethasone randomized

Experimental group

Description:

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Treatment:

Drug: Dexamethasone

Burr hole craniostomy observational

Other group

Description:

Observational cohort of patients selecting burr hole craniostomy

Treatment:

Procedure: Burr Hole Craniostomy

Dexamethasone observational

Other group

Description:

Observational cohort of patients treated with dexamethasone protocol

Treatment:

Drug: Dexamethasone