Chronic Subdural HematomaPhase 2/3NCT02938468
Mgt of Chronic Subdural Hematoma Using Dexamethasone
A Phase 2/3 study testing Dexamethasone and Any surgical intervention aim at treating chronic subdural hematoma in people with Chronic Subdural Hematoma, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Dexamethasone and Any surgical intervention aim at treating chronic subdural hematoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2016to Sep 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 yrs
- subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
- patient must be symptomatic
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Michael Opoku-Darko, MD.,MSc. contact
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N1N4
Clare Gallagher, MD.,PhD, 4039448447, galclare@gmail.com
Michael Opoku-Darko, MD.,MSc., mopokuda@ucalgary.ca
About this study
Official title: Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Dexamethasone, Any surgical intervention aim at treating chronic subdural hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Any surgical intervention aim at treating chronic subdural hematomaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | 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 Receives: Procedure: Any surgical intervention aim at treating chronic subdural hematoma |
| Dexamethasone | Experimental | Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rates
Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.
Measured: 3 months
Secondary outcomes (10)
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.
Measured: 3 months
Modified Ranking Scale
Functional outcome
Measured: 1, 3 and 6 months after treatment
Barthel index
Functional outcome
Measured: 1, 3 and 6 months after treatment
Glasgow Outcome Scale
Functional outcome
Measured: 1, 3 and 6 months after treatment
Glasgow Coma Scale
Functional outcome
Measured: 1, 3 and 6 months after treatment
Markwalder score
Functional outcome
Measured: 1, 3 and 6 months after treatment
Clinical improvement (Categorized as resolved, improved, unchanged or worse)
Categorized as resolved, improved, unchanged or worse
Measured: 1, 3 and 6 months after treatment
Radiologic outcomes (Change in hematoma volume)
Measured as change in hematoma volume
Measured: 1, 3 and 6 months after treatment
Quality of Life measured using the EQ-5D-5L
Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.
Measured: 1, 3 and 6 months after treatment
Mortality
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start17 Sep 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938468
- Sponsor's protocol ID
- REB16-0219
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02938468
- Acronym / sponsor ID
- REB16-0219
- Conditions
- Chronic Subdural Hematoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Any surgical intervention aim at treating chronic subdural hematomaPatients 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 |
| Dexamethasone | Experimental | Drug: DexamethasonePatients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 yrs
- subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
- patient must be symptomatic
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decadron | Drug | Dexamethasone |
| Any surgical intervention aim at treating chronic subdural hematoma | Procedure or surgery | Surgery |
Primary outcome
Failure rates
Time frame: 3 months
Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.
10 secondary outcomes
Recurrence rate
Time frame: 3 months
Modified Ranking Scale
Time frame: 1, 3 and 6 months after treatment
Barthel index
Time frame: 1, 3 and 6 months after treatment
Glasgow Outcome Scale
Time frame: 1, 3 and 6 months after treatment
Glasgow Coma Scale
Time frame: 1, 3 and 6 months after treatment
Markwalder score
Time frame: 1, 3 and 6 months after treatment
Clinical improvement (Categorized as resolved, improved, unchanged or worse)
Time frame: 1, 3 and 6 months after treatment
Radiologic outcomes (Change in hematoma volume)
Time frame: 1, 3 and 6 months after treatment
Quality of Life measured using the EQ-5D-5L
Time frame: 1, 3 and 6 months after treatment
Mortality
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Opoku-Darko, MD.,MSc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone and Any surgical intervention aim at treating chronic subdural hematoma in people with Chronic Subdural Hematoma, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clare Gallagher, MD.,PhD. (4039448447, galclare@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rates (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.