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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 3, 2014
First Posted Date  ICMJE April 11, 2014
Results First Submitted Date  ICMJE August 20, 2018
Results First Posted Date  ICMJE December 11, 2018
Last Update Posted Date December 11, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: April 8, 2014)
modified Rankin Score of 0, 1 or 2 [ Time Frame: 6 months after diagnosis ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 19, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2014)
300
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02111785
Other Study ID Numbers  ICMJE 17294
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer De Jong University of Virginia
PRS Account University of Virginia
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP