drugset / Trial / NCT02111785

Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

NCT02111785

Phase 2/3 Terminated 10 enrolled University of Virginia
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2014-03
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg Oral

Indications

No indication recorded.