Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)
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ClinicalTrials.gov Identifier: NCT02111785 |
Recruitment Status :
Terminated
(Accrual too slow; Study P.I. passed away.)
First Posted : April 11, 2014
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
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Chronic Subdural Hematoma | Drug: Dexamethasone Procedure: Burr Hole Craniostomy | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
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Active Comparator: Burr Hole Craniostomy randomized
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
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Procedure: Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Other Name: Burr hole drainage |
Experimental: Dexamethasone randomized
Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
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Drug: Dexamethasone
Treatment with a short course of oral dexamethasone
Other Name: dex |
Burr hole craniostomy observational
Observational cohort of patients selecting burr hole craniostomy
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Procedure: Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH
Other Name: Burr hole drainage |
Dexamethasone observational
Observational cohort of patients treated with dexamethasone protocol
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Drug: Dexamethasone
Treatment with a short course of oral dexamethasone
Other Name: dex |
- Number of Participants With a Modified Rankin Score of 0, 1 or 2 [ Time Frame: 6 months after diagnosis ]
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.
- Rate of Treatment Failure [ Time Frame: 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 [ Time Frame: 6 months after hospital discharge ]
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.
- Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up [ Time Frame: 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 [ Time Frame: 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.
- Rate of Radiographic Resolution of Chronic Subdural Hematoma [ Time Frame: 6 months after diagnosis ]The data were not collected.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111785
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 |
Study Director: | Jennifer De Jong | University of Virginia |
Documents provided by University of Virginia:
Responsible Party: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT02111785 |
Other Study ID Numbers: |
17294 |
First Posted: | April 11, 2014 Key Record Dates |
Results First Posted: | December 11, 2018 |
Last Update Posted: | December 11, 2018 |
Last Verified: | November 2018 |
Dexamethasone Burr hole craniostomy Chronic subdural hematoma |
Hematoma, Subdural Hematoma, Subdural, Chronic Hematoma Hemorrhage Pathologic Processes Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Vascular Diseases |
Cardiovascular Diseases Wounds and Injuries Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |