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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
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Dexamethasone Procedure: Burr Hole Craniostomy Phase 2 Phase 3

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Burr Hole Craniostomy randomized
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
 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
 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
 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
 Drug: Dexamethasone
Treatment with a short course of oral dexamethasone
Other Name: dex


Outcome Measures
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Primary Outcome Measures :
  1. 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

    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 Outcome Measures :
  1. 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

  2. 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

    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.


  3. 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.

  4. 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.



Other Outcome Measures:
  1. Rate of Radiographic Resolution of Chronic Subdural Hematoma [ Time Frame: 6 months after diagnosis ]
    The data were not collected.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Study Director: Jennifer De Jong University of Virginia
  Study Documents (Full-Text)

Documents provided by University of Virginia:
Study Protocol and Statistical Analysis Plan  [PDF] October 20, 2015

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT02111785     History of Changes
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

Keywords provided by University of Virginia:
Dexamethasone
Burr hole craniostomy
Chronic subdural hematoma

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
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 acetate
Dexamethasone
BB 1101
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