Mgt of Chronic Subdural Hematoma Using Dexamethasone
Primary Purpose
Chronic Subdural Hematoma
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
Any surgical intervention aim at treating chronic subdural hematoma
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 yrs
- subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
- patient must be symptomatic
Exclusion Criteria:
- Glasgow Coma Scale (GCS) ≤ 12
- patients needing craniotomy at the discretion of the on call neurosurgeon
hemiparesis with less than antigravity (≤ 3/5 medical research council scale) strength in any testable myotomes
°≥ 2 seizures at presentation or history of epilepsy
- subdural hematoma with an underlying lesion or condition such as tumor, arachnoid cyst, presence of a ventriculoperitoneal shunt or vascular malformation
- contraindication to dexamethasone including allergy or hypersensitivity to dexamethasone, immunocompromised/immunosuppressed patients, uncontrolled diabetes, untreated known peptic ulcer disease
- pregnant/breastfeeding mothers
- acute infection including latent/active tuberculosis (TB)
- history of psychosis
- anticoagulated for mechanical heart valve or arterial stent (i.e. coronary, carotid, or peripheral) placement
- small volume, non-operable subdural collection
Sites / Locations
- University of CalgaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Surgery
Dexamethasone
Arm Description
Patients in this arm will receive any form if surgical intervention (i.e. bedside burrhole craniostomy, 2 burrhole washout, craniotomy, endoscopy etc.) for treatment of their chronic subdural hematoma
Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma
Outcomes
Primary Outcome Measures
Failure rates
Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.
Secondary Outcome Measures
Recurrence rate
Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.
Modified Ranking Scale
Functional outcome
Barthel index
Functional outcome
Glasgow Outcome Scale
Functional outcome
Glasgow Coma Scale
Functional outcome
Markwalder score
Functional outcome
Clinical improvement (Categorized as resolved, improved, unchanged or worse)
Categorized as resolved, improved, unchanged or worse
Radiologic outcomes (Change in hematoma volume)
Measured as change in hematoma volume
Quality of Life measured using the EQ-5D-5L
Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.
Mortality
Full Information
NCT ID
NCT02938468
First Posted
September 21, 2016
Last Updated
June 29, 2020
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT02938468
Brief Title
Mgt of Chronic Subdural Hematoma Using Dexamethasone
Official Title
Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2016 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.
Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.
Detailed Description
Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. The one-year incidence rate is 1 to 8.2 per 100 000 in those 65 years or older. Advanced age is one of several risk factors and the incidence is expected to increase due to improved life expectancy. Other risk factors include brain atrophy, chronic alcoholism, intracranial hypotension, male gender and coagulopathy (including antiplatelet and antithrombotic therapy).
Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.
Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive any form if surgical intervention (i.e. bedside burrhole craniostomy, 2 burrhole washout, craniotomy, endoscopy etc.) for treatment of their chronic subdural hematoma
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Type
Procedure
Intervention Name(s)
Any surgical intervention aim at treating chronic subdural hematoma
Primary Outcome Measure Information:
Title
Failure rates
Description
Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.
Time Frame
3 months
Title
Modified Ranking Scale
Description
Functional outcome
Time Frame
1, 3 and 6 months after treatment
Title
Barthel index
Description
Functional outcome
Time Frame
1, 3 and 6 months after treatment
Title
Glasgow Outcome Scale
Description
Functional outcome
Time Frame
1, 3 and 6 months after treatment
Title
Glasgow Coma Scale
Description
Functional outcome
Time Frame
1, 3 and 6 months after treatment
Title
Markwalder score
Description
Functional outcome
Time Frame
1, 3 and 6 months after treatment
Title
Clinical improvement (Categorized as resolved, improved, unchanged or worse)
Description
Categorized as resolved, improved, unchanged or worse
Time Frame
1, 3 and 6 months after treatment
Title
Radiologic outcomes (Change in hematoma volume)
Description
Measured as change in hematoma volume
Time Frame
1, 3 and 6 months after treatment
Title
Quality of Life measured using the EQ-5D-5L
Description
Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.
Time Frame
1, 3 and 6 months after treatment
Title
Mortality
Time Frame
1, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 yrs
subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
patient must be symptomatic
Exclusion Criteria:
Glasgow Coma Scale (GCS) ≤ 12
patients needing craniotomy at the discretion of the on call neurosurgeon
hemiparesis with less than antigravity (≤ 3/5 medical research council scale) strength in any testable myotomes
°≥ 2 seizures at presentation or history of epilepsy
subdural hematoma with an underlying lesion or condition such as tumor, arachnoid cyst, presence of a ventriculoperitoneal shunt or vascular malformation
contraindication to dexamethasone including allergy or hypersensitivity to dexamethasone, immunocompromised/immunosuppressed patients, uncontrolled diabetes, untreated known peptic ulcer disease
pregnant/breastfeeding mothers
acute infection including latent/active tuberculosis (TB)
history of psychosis
anticoagulated for mechanical heart valve or arterial stent (i.e. coronary, carotid, or peripheral) placement
small volume, non-operable subdural collection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Gallagher, MD.,PhD.
Phone
4039448447
Email
galclare@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Opoku-Darko, MD.,MSc.
Email
mopokuda@ucalgary.ca
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Gallagher, MD.,PhD
Phone
4039448447
Email
galclare@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Opoku-Darko, MD.,MSc.
Email
mopokuda@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Clare Gallagher, MD.,PhD.
First Name & Middle Initial & Last Name & Degree
Steve Casha, MD.,PhD.
First Name & Middle Initial & Last Name & Degree
Michael Opoku-Darko, MD.,MSc.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mgt of Chronic Subdural Hematoma Using Dexamethasone
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