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Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)

Primary Purpose

Chronic Subdural Hematoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Burr Hole Craniostomy
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Dexamethasone, Burr hole craniostomy, Chronic subdural hematoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Other

Other

Arm Label

Burr Hole Craniostomy randomized

Dexamethasone randomized

Burr hole craniostomy observational

Dexamethasone observational

Arm Description

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Observational cohort of patients selecting burr hole craniostomy

Observational cohort of patients treated with dexamethasone protocol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
April 3, 2014
Last Updated
November 19, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02111785
Brief Title
Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Acronym
DECS
Official Title
The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Accrual too slow; Study P.I. passed away.
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Dexamethasone, Burr hole craniostomy, Chronic subdural hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer De Jong
Organizational Affiliation
University of Virginia
Official's Role
Study Director
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

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