Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

— DECS  

Official title:

The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02111785
• Other study ID #: 17294
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Dexamethasone
Treatment with a short course of oral dexamethasone

Procedure:
• Burr Hole Craniostomy
Treatment with surgical burr hole craniostomy and evacuation of SDH

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Radiographic Resolution of Chronic Subdural Hematoma	The data were not collected.	6 months after diagnosis
Primary	Number of Participants With a Modified Rankin Score of 0, 1 or 2	The Modified Rankin Scale (mRS); The mRS is evaluated as follows: 0 - No symptoms; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.; Higher scores on the mRS scale mean a worse outcome.	6 months after diagnosis
Secondary	Rate of Treatment Failure	This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group	6 months after diagnosis
Secondary	Participants With Modified Rankin Score 0, 1 or 2 at 6 Months	The Modified Rankin Scale (mRS); The mRS is evaluated as follows: 0 - No symptoms; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.; Higher scores on the mRS scale mean a worse outcome.	6 months after hospital discharge
Secondary	Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up	Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome.	6 months after hospital discharge
Secondary	Participants With a Markwalder Grading Score of 0	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.	6 months after hospital discharge