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

• ClinicalTrials.gov Identifier: NCT02111785
• Recruitment Status: Terminated
• First Posted: April 11, 2014
• Results First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Sponsor: University of Virginia
• Information provided by (Responsible Party): University of Virginia

Tracking Information

• First Submitted Date: April 3, 2014
• First Posted Date: April 11, 2014
• Results First Submitted Date: August 20, 2018
• Results First Posted Date: December 11, 2018
• Last Update Posted Date: December 11, 2018
• Study Start Date: March 2014
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 19, 2018)

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.

• Original Primary Outcome Measures (submitted: April 8, 2014): modified Rankin Score of 0, 1 or 2 [ Time Frame: 6 months after diagnosis ]

Current Secondary Outcome Measures (submitted: November 19, 2018)

• 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

  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 [ 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.

Original Secondary Outcome Measures (submitted: April 8, 2014)

• 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
• modified Rankin Score [ Time Frame: Hospital discharge, 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  modified Rankin Score at follow-up visits
• Glasgow Coma Score [ Time Frame: Hospital discharge, 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  Glasgow Comas Score at follow-up visits
• Markwalder Grading Score [ Time Frame: Hospital discharge, 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  Markwalder Grading Score at follow-up visits

Current Other Pre-specified Outcome Measures (submitted: November 19, 2018)

Rate of Radiographic Resolution of Chronic Subdural Hematoma [ Time Frame: 6 months after diagnosis ]

The data were not collected.

• Original Other Pre-specified Outcome Measures (submitted: April 8, 2014): Rate of Radiographic Resolution of Chronic Subdural Hematoma [ Time Frame: 6 months after diagnosis ]

Descriptive Information

• Brief Title: Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
• Official Title: The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Subdural Hematoma

Intervention

• Drug: Dexamethasone
  Treatment with a short course of oral dexamethasone
  Other Name: dex
• Procedure: Burr Hole Craniostomy
  Treatment with surgical burr hole craniostomy and evacuation of SDH
  Other Name: Burr hole drainage

Study Arms

• Active Comparator: Burr Hole Craniostomy randomized
  Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
  Intervention: Procedure: Burr Hole Craniostomy
• Experimental: Dexamethasone randomized
  Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
  Intervention: Drug: Dexamethasone
• Burr hole craniostomy observational
  Observational cohort of patients selecting burr hole craniostomy
  Intervention: Procedure: Burr Hole Craniostomy
• Dexamethasone observational
  Observational cohort of patients treated with dexamethasone protocol
  Intervention: Drug: Dexamethasone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 19, 2018): 10
• Original Estimated Enrollment (submitted: April 8, 2014): 300
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02111785
• Other Study ID Numbers: 17294
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Virginia
• Study Sponsor: University of Virginia
• Collaborators: Not Provided

Investigators

• Study Director: Jennifer De Jong; University of Virginia

• PRS Account: University of Virginia
• Verification Date: November 2018