Clinical Trial: Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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. 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 is 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 is: 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 Summary:
Sponsor: University of Virginia

Current Primary Outcome: modified Rankin Score of 0, 1 or 2 [ Time Frame: 6 months after diagnosis ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  modified Rankin Score at follow-up visits
• Glasgow Coma Score [ Time Frame: Hospital discharge (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  Glasgow Comas Score at follow-up visits
• Markwalder Grading Score [ Time Frame: Hospital discharge (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
  Markwalder Grading Score at follow-up visits

Original Secondary Outcome:

• 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

Information By: University of Virginia

Dates:
Date Received: April 3, 2014
Date Started: March 2014
Date Completion: December 2017
Last Updated: October 25, 2016
Last Verified: October 2016