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Burr hole craniostomy observational for Subdural Hematoma (DECS Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after diagnosis
Awards & highlights

DECS Trial 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.

Eligible Conditions
  • Subdural Hematoma

DECS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Modified Rankin Score of 0, 1 or 2
Secondary outcome measures
Participants With Modified Rankin Score 0, 1 or 2 at 6 Months
Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up
Participants With a Markwalder Grading Score of 0
+1 more
Other outcome measures
Rate of Radiographic Resolution of Chronic Subdural Hematoma

DECS Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Dexamethasone randomizedExperimental Treatment1 Intervention
Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
Group II: Dexamethasone observationalExperimental Treatment1 Intervention
Observational cohort of patients treated with dexamethasone protocol
Group III: Burr hole craniostomy observationalExperimental Treatment1 Intervention
Observational cohort of patients selecting burr hole craniostomy
Group IV: Burr Hole Craniostomy randomizedActive Control1 Intervention
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Burr Hole Craniostomy
2012
N/A
~250

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
761 Previous Clinical Trials
1,256,028 Total Patients Enrolled
Jennifer De JongStudy DirectorUniversity of Virginia
~1 spots leftby Jun 2025