Trial Outcomes & Findings for Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (NCT NCT02111785)

Results Overview

The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Higher scores on the mRS scale mean a worse outcome.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

6 months after diagnosis

Results posted on

2018-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Burr Hole Craniostomy Randomized Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Overall Study STARTED	3	5	1	1
Overall Study COMPLETED	3	4	1	1
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Burr Hole Craniostomy Randomized Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Overall Study Death	0	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=5 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=5 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=3 Participants	1 Participants n=5 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	3 Participants n=10 Participants
Age, Categorical >=65 years	1 Participants n=3 Participants	4 Participants n=5 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants	7 Participants n=10 Participants
Age, Continuous	75.3 years n=3 Participants	72.6 years n=5 Participants	76 years n=1 Participants	74 years n=1 Participants	73.3 years n=10 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	0 Participants n=5 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=3 Participants	5 Participants n=5 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants	10 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	5 participants n=5 Participants	1 participants n=1 Participants	1 participants n=1 Participants	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 6 months after diagnosis

Population: 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 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Higher scores on the mRS scale mean a worse outcome.

Outcome measures

Outcome measures
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=5 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Number of Participants With a Modified Rankin Score of 0, 1 or 2	3 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months after diagnosis

Population: Reflects population analyzed for treatment failure. The one patient in the dexamethasone randomized group who died was not analyzed for this secondary outcome.

This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group

Outcome measures

Outcome measures
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=4 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Rate of Treatment Failure	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months after hospital discharge

The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Higher scores on the mRS scale mean a worse outcome.

Outcome measures

Outcome measures
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=5 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Participants With Modified Rankin Score 0, 1 or 2 at 6 Months	3 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months after hospital discharge

Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome.

Outcome measures

Outcome measures
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=5 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up	3 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months after hospital discharge

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.

Outcome measures

Outcome measures
Measure	Burr Hole Craniostomy Randomized n=3 Participants Group receiving burr hole craniostomy and drainage of chronic subdural hematoma Burr Hole Craniostomy	Dexamethasone Randomized n=5 Participants Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days Dexamethasone	Burr Hole Craniostomy Observational n=1 Participants Observational cohort of patients selecting burr hole craniostomy Burr Hole Craniostomy	Dexamethasone Observational n=1 Participants Observational cohort of patients treated with dexamethasone protocol Dexamethasone
Participants With a Markwalder Grading Score of 0	3 Participants	4 Participants	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after diagnosis

The data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Burr Hole Craniostomy Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Burr Hole Craniostomy Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Raper

Department of Neurosurgery, University of Virginia Health System

Phone: 4349823244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place