- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02111785
Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)
The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Burr Hole Craniostomy randomized
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
|
Treatment with surgical burr hole craniostomy and evacuation of SDH
Other Names:
|
Experimental: Dexamethasone randomized
Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
|
Treatment with a short course of oral dexamethasone
Other Names:
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Other: Burr hole craniostomy observational
Observational cohort of patients selecting burr hole craniostomy
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Treatment with surgical burr hole craniostomy and evacuation of SDH
Other Names:
|
Other: Dexamethasone observational
Observational cohort of patients treated with dexamethasone protocol
|
Treatment with a short course of oral dexamethasone
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Higher scores on the mRS scale mean a worse outcome. |
6 months after diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months after diagnosis
|
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
Higher scores on the mRS scale mean a worse outcome. |
6 months after hospital discharge
|
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.
|
6 months after hospital discharge
|
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. |
6 months after hospital discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Radiographic Resolution of Chronic Subdural Hematoma
Time Frame: 6 months after diagnosis
|
The data were not collected.
|
6 months after diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jennifer De Jong, University of Virginia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- 17294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Burr Hole Craniostomy
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University of ZurichStryker European Operations BVCompletedHematoma, Subdural, Chronic | Hematoma, Subdural, Intracranial | Haematoma;Subdural;TraumaticSwitzerland
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