Chronic Subdural Hematoma
Conditions
Keywords
Dexamethasone, Burr hole craniostomy, Chronic subdural hematoma
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.
Interventions
DRUGDexamethasone
Treatment with a short course of oral dexamethasone
PROCEDUREBurr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Radiographic Resolution of Chronic Subdural Hematoma | 6 months after diagnosis | The data were not collected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Burr Hole Craniostomy Randomized Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
Burr Hole Craniostomy | 3 |
| Dexamethasone Randomized Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
Dexamethasone | 5 |
| Burr Hole Craniostomy Observational Observational cohort of patients selecting burr hole craniostomy
Burr Hole Craniostomy | 1 |
| Dexamethasone Observational Observational cohort of patients treated with dexamethasone protocol
Dexamethasone | 1 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Dexamethasone Randomized | Burr Hole Craniostomy Observational | Dexamethasone Observational | Burr Hole Craniostomy Randomized | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 72.6 years | 76 years | 74 years | 75.3 years | 73.3 years |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 5 participants | 1 participants | 1 participants | 3 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 1 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 5 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 5 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 0 / 1 | 0 / 1 |
Outcome results
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 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.
Time frame: 6 months after diagnosis
Population: Number of Participants with a modified Rankin Score of 0, 1 or 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burr Hole Craniostomy Randomized | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 3 Participants |
| Dexamethasone Randomized | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 4 Participants |
| Burr Hole Craniostomy Observational | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 1 Participants |
| Dexamethasone Observational | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 1 Participants |
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.
Time frame: 6 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burr Hole Craniostomy Randomized | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 3 Participants |
| Dexamethasone Randomized | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 4 Participants |
| Burr Hole Craniostomy Observational | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 1 Participants |
| Dexamethasone Observational | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 1 Participants |
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.
Time frame: 6 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burr Hole Craniostomy Randomized | Participants With a Markwalder Grading Score of 0 | 3 Participants |
| Dexamethasone Randomized | Participants With a Markwalder Grading Score of 0 | 4 Participants |
| Burr Hole Craniostomy Observational | Participants With a Markwalder Grading Score of 0 | 1 Participants |
| Dexamethasone Observational | Participants With a Markwalder Grading Score of 0 | 1 Participants |
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 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.
Time frame: 6 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burr Hole Craniostomy Randomized | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 3 Participants |
| Dexamethasone Randomized | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 4 Participants |
| Burr Hole Craniostomy Observational | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 1 Participants |
| Dexamethasone Observational | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 1 Participants |
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
Time frame: 6 months after diagnosis
Population: Reflects population analyzed for treatment failure. The one patient in the dexamethasone randomized group who died was not analyzed for this secondary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burr Hole Craniostomy Randomized | Rate of Treatment Failure | 0 Participants |
| Dexamethasone Randomized | Rate of Treatment Failure | 0 Participants |
| Burr Hole Craniostomy Observational | Rate of Treatment Failure | 0 Participants |
| Dexamethasone Observational | Rate of Treatment Failure | 0 Participants |
Other Pre-specified
Rate of Radiographic Resolution of Chronic Subdural Hematoma
The data were not collected.
Time frame: 6 months after diagnosis