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Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)

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ClinicalTrials.gov Identifier: NCT02111785
Recruitment Status : Terminated (Accrual too slow; Study P.I. passed away.)
First Posted : April 11, 2014
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Subdural Hematoma
Interventions Drug: Dexamethasone
Procedure: Burr Hole Craniostomy
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Period Title: Overall Study
Started 3 5 1 1
Completed 3 4 1 1
Not Completed 0 1 0 0
Reason Not Completed
Death             0             1             0             0
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational Total
Hide Arm/Group Description

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone

 Total of all reporting groups
Overall Number of Baseline Participants 3 5 1 1 10
Hide Baseline Analysis Population Description
Population represents patients meeting inclusion/exclusion criteria who were enrolled in the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 1 participants 1 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
1
  20.0%
0
   0.0%
0
   0.0%
3
  30.0%
>=65 years
1
  33.3%
4
  80.0%
1
 100.0%
1
 100.0%
7
  70.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 1 participants 1 participants 10 participants
75.3
(54 to 88)
72.6
(47 to 87)
76
(76 to 76)
74
(74 to 74)
73.3
(47 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 1 participants 1 participants 10 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
5
 100.0%
1
 100.0%
1
 100.0%
10
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 5 participants 1 participants 1 participants 10 participants
3 5 1 1 10
1.Primary Outcome
Title Number of Participants With a Modified Rankin Score of 0, 1 or 2
Hide Description

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.
Time Frame 6 months after diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with a modified Rankin Score of 0, 1 or 2.
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Overall Number of Participants Analyzed 3 5 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
4
  80.0%
1
 100.0%
1
 100.0%
2.Secondary Outcome
Title Rate of Treatment Failure
Hide Description This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group
Time Frame 6 months after diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Reflects population analyzed for treatment failure. The one patient in the dexamethasone randomized group who died was not analyzed for this secondary outcome.
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

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

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone: Treatment with a short course of oral dexamethasone

Observational cohort of patients selecting burr hole craniostomy

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

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone: Treatment with a short course of oral dexamethasone
Overall Number of Participants Analyzed 3 4 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Participants With Modified Rankin Score 0, 1 or 2 at 6 Months
Hide Description

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.
Time Frame 6 months after hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Overall Number of Participants Analyzed 3 5 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
4
  80.0%
1
 100.0%
1
 100.0%
4.Secondary Outcome
Title Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up
Hide Description Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome.
Time Frame 6 months after hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Overall Number of Participants Analyzed 3 5 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
4
  80.0%
1
 100.0%
1
 100.0%
5.Secondary Outcome
Title Participants With a Markwalder Grading Score of 0
Hide Description

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.
Time Frame 6 months after hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description:

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Overall Number of Participants Analyzed 3 5 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
4
  80.0%
1
 100.0%
1
 100.0%
6.Other Pre-specified Outcome
Title Rate of Radiographic Resolution of Chronic Subdural Hematoma
Hide Description The data were not collected.
Time Frame 6 months after diagnosis
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description Adverse events assessed included number of participants experiencing infection, seizure, medication intolerance, DVT and PE.
 
Arm/Group Title Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Hide Arm/Group Description

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Burr Hole Craniostomy

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone

Observational cohort of patients selecting burr hole craniostomy

Burr Hole Craniostomy

Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
All-Cause Mortality
Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/5 (20.00%)   0/1 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/5 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Burr Hole Craniostomy Randomized Dexamethasone Randomized Burr Hole Craniostomy Observational Dexamethasone Observational
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/5 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Raper
Organization: Department of Neurosurgery, University of Virginia Health System
Phone: 4349823244
EMail: raper@virginia.edu
Layout table for additonal information
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT02111785    
Other Study ID Numbers: 17294
First Submitted: April 3, 2014
First Posted: April 11, 2014
Results First Submitted: August 20, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018