Chronic Subdural Hematoma Clinical Trial
Official title:
The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06347796 -
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
|
N/A | |
Recruiting |
NCT04065113 -
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
|
N/A | |
Recruiting |
NCT02938468 -
Mgt of Chronic Subdural Hematoma Using Dexamethasone
|
Phase 2/Phase 3 | |
Completed |
NCT03307395 -
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
|
N/A | |
Terminated |
NCT04502745 -
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
|
N/A | |
Terminated |
NCT03353259 -
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
|
Phase 2/Phase 3 | |
Recruiting |
NCT02568124 -
Tranexamic Acid in Chronic Subdural Hematomas
|
Phase 2/Phase 3 | |
Completed |
NCT02282228 -
Detecting Chronic Subdural Hematoma With Microwave Technology
|
N/A | |
Recruiting |
NCT05143216 -
High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
|
||
Active, not recruiting |
NCT04816591 -
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
|
N/A | |
Recruiting |
NCT06401772 -
The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
|
N/A | |
Completed |
NCT06134206 -
Burr Hole Ultrasound Study
|
N/A | |
Recruiting |
NCT03666949 -
General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
|
N/A | |
Recruiting |
NCT03280212 -
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma
|
Phase 3 | |
Completed |
NCT03447327 -
Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
|
N/A | |
Recruiting |
NCT05374681 -
Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
|
N/A | |
Recruiting |
NCT05267184 -
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
|
N/A | |
Not yet recruiting |
NCT05900557 -
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
|
N/A | |
Completed |
NCT02757235 -
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
|
N/A | |
Recruiting |
NCT05599217 -
Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
|