Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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