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Trial registered on ANZCTR


Registration number
ACTRN12621000202864p
Ethics application status
Submitted, not yet approved
Date submitted
28/06/2020
Date registered
26/02/2021
Date last updated
26/02/2021
Date data sharing statement initially provided
26/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of middle meningeal artery embolisation as primary treatment for chronic subdural haematoma in adult patients

Scientific title
The efficacy of middle meningeal artery embolisation as primary treatment for chronic subdural haematoma in adult patients
Secondary ID [1] 301644 0
None
Universal Trial Number (UTN)
U1111-1254-3825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic subdural haematoma 318056 0
Condition category
Condition code
Surgery 316088 316088 0 0
Surgical techniques
Neurological 316925 316925 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 (stable patients): Middle meningeal embolization
-Materials: Oynx (Liquid embolic agent)
-Procedure: MMA embolization
-Duration: approx 60mins
-Who: One of the 3 interventional neuroradiologists at The Canberra Hospital
-One off treatment for chronic subdural haematoma
-Location: The Canberra Hospital
-Monitoring: A data safety monitoring board has been formed by 4 external reviewers including Dr Yash Gawarikar (Neurologist), Prof Christian Lueck (Neurologist), Dr Justin Pik (Neurosurgeon) and A/Prof John Cockburn (Radiologist). The board will review the operation reports and medical records to ensure the safety of the participants and that our complication rates are comparable to that observed in the literature.
Intervention code [1] 317949 0
Treatment: Surgery
Comparator / control treatment
Arm 2 (stable patients): observation
-Outpatient clinic review with repeat CT brain at 6 weeks, 3 months and 6 months
-By the treating neurosurgery team (the admitting neurosurgeon and the 3 registrars)
-At the Canberra Hospital
Control group
Active

Outcomes
Primary outcome [1] 324279 0
Symptomatic recurrent/residual chronic subdural haematoma that requires surgical evacuation
-Symptomatic recurrence is defined as cSDH on follow-up CTs demonstrating =>1cm in maximal thickness or >= 0.5cm midline line shift or resulting in neurological deficits including confusion and lateralising weakness
Timepoint [1] 324279 0
Outpatient follow-up with CT Scan at 6 weeks, 3 months and 6 months
Secondary outcome [1] 384244 0
Radiological resolution of chronic subdural haematoma
-maximal thickness of residual haematoma on serial follow-up CT scans will be measured at 6 weeks, 3 months and 6 months.
Timepoint [1] 384244 0
For intervention group: At 6 weeks, 3 months and 6 months post-procedure
For control: At 6 weeks, 3 months and 6 months from enrolment
Secondary outcome [2] 384245 0
Composite embolisation-related complications including:
Infection, pseudoaneurysm, retroperitoneal haematoma, allergic reactions to contrast, DVT/PE, MI, death, stroke, intracerebral haemorrhage

All above complications will be assessed by daily clinical examination during inpatient stay following the embolisation procedure. Appropriate investigations will be arranged if indicated.
-Infection, allergic reactions: blood tests
-Pseudoaneurysm: ultra-sound
-Retroperitoneal haematoma: CT abdomen
-DVT/PE: Ultra-sound of lower limbs, CT pulmonary angiogram
-Stroke and intracerebral haemorrhage: CT Brain
Timepoint [2] 384245 0
From admission until hospital discharge
Secondary outcome [3] 384246 0
Hospital length of stay
-Assessed via reviewing of hospital record
Timepoint [3] 384246 0
from admission until hospital discharge
Secondary outcome [4] 384247 0
Modified Rankin Scale
Timepoint [4] 384247 0
On admission
Upon discharge
At 6 weeks, 3 months and 6 months follow-ups

Eligibility
Key inclusion criteria
Patient aged 18 or above with a diagnosis of chronic subdural haematoma. A patient is considered stable (i.e. not requiring emergency surgical evacuation) if and only if they fit all of the following criteria:
1. GCS => 13
2. Lateralised weakness if present >= 4/5 power
3. No other neurological deficits

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant contraindications to surgery or angiography (eg. renal failure and allergies)
Acute subdural haematoma
Chronic subdural haematoma related to an underlying pathology other than trauma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
150 envelopes with 75 containing an embolisation label and the other 75 containing an non-embolisation label will be randomly shuffled and subsequently assigned a number from 1 to 150.

The envelopes will then be allocated to participants in numerical order, thereby envelope 1 will be assigned to the first participant and so on.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Stable patients: the anticipated recurrence rate will be 3% in the MMA embolisation group (Arm 1) and the anticipated rate of failed conservative management will be 30% in the observation group (Arm 2). The required sample size in each group is estimated to be 28 patients for alpha = 0.05 and power = 80%.


A independent T-test will be used to compare the means between arm 1 and 2.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 16989 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 30653 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 306078 0
Hospital
Name [1] 306078 0
The Canberra Hospital
Address [1] 306078 0
Yamba Drive, Garran, ACT 2605
Country [1] 306078 0
Australia
Funding source category [2] 306079 0
Commercial sector/Industry
Name [2] 306079 0
Terumo Microvention
Address [2] 306079 0
Level 29, Australia Square, 264 George Street, Sydney, NSW 2000, Australia, Attn: Kevin Culpan
Country [2] 306079 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Yamba Drive, Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 306541 0
None
Name [1] 306541 0
None
Address [1] 306541 0
None
Country [1] 306541 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306300 0
ACT Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 306300 0
PO Box 11 Woden ACT 2606, Canberra Hospital, Building 10 Level 6
Ethics committee country [1] 306300 0
Australia
Date submitted for ethics approval [1] 306300 0
07/09/2020
Approval date [1] 306300 0
Ethics approval number [1] 306300 0

Summary
Brief summary
Chronic subdural haematoma (cSDH) is one of the most common neurosurgical conditions and its frequency continues to rise as a result of the aging population and the increasing use of anticoagulation and antiplatelet medications. While there are no established guidelines for its management, symptomatic cSDHs are usually treated with surgical evacuation. The reported recurrence rates following surgical evacuation in the literature vary widely from 2% to 37%, with most estimates ranging between 20% and 30%.

Recent studies have suggested middle meningeal artery (MMA) embolisation to be a potential alternative treatment for cSDH. Numerous case reports and series have demonstrated MMA embolisation as a safe primary treatment for cSDHs or as an adjunct treatment following surgical evacuation.

We aim to conduct the first randomised controlled trial to further confirm the efficacy of MMA embolisation.
-Stable cSDH patients who do not require urgent surgical evacuation will be randomly allocated to observation or to receive MMA embolisation.
-We aim to demonstrate that MMA embolisation can reduce the need for surgical evacuation in stable patients


Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103418 0
Dr Peter Mews
Address 103418 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran, ACT 2605
Country 103418 0
Australia
Phone 103418 0
+61 2 5124 4080
Fax 103418 0
Email 103418 0
Peter.Mews@act.gov.au
Contact person for public queries
Name 103419 0
Dr Alexander Lam
Address 103419 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran, ACT 2605
Country 103419 0
Australia
Phone 103419 0
+61 2 5124 4080
Fax 103419 0
Email 103419 0
Neurosurgery@act.gov.au
Contact person for scientific queries
Name 103420 0
Dr Alexander Lam
Address 103420 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 103420 0
Australia
Phone 103420 0
+61 2 5124 4080
Fax 103420 0
Email 103420 0
Neurosurgery@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data except for personally identifiable data will be shared
When will data be available (start and end dates)?
Following completion of the trial
-Data will be available for 5 years after publication
Available to whom?
To other researchers who are conducting similar studies
Available for what types of analyses?
Systemic review and meta-analysis
How or where can data be obtained?
Request to be made by emailing to the investigators via the Neurosurgery Office at The Canberra Hospital - Neurosurgery@act.gov.au
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 8353 0
Study protocol
Citation [1] 8353 0
.
Link [1] 8353 0
Email [1] 8353 0
Other [1] 8353 0
.
Summary results
No Results