Chronic Subdural Hematoma Clinical Trial
— DECSOfficial title:
The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Verified date | November 2018 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of Radiographic Resolution of Chronic Subdural Hematoma | The data were not collected. | 6 months after diagnosis | |
Primary | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. Higher scores on the mRS scale mean a worse outcome. |
6 months after diagnosis | |
Secondary | Rate of Treatment Failure | This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group | 6 months after diagnosis | |
Secondary | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. Higher scores on the mRS scale mean a worse outcome. |
6 months after hospital discharge | |
Secondary | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome. | 6 months after hospital discharge | |
Secondary | Participants With a Markwalder Grading Score of 0 | 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. |
6 months after hospital discharge |
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