Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000263897
Ethics application status
Approved
Date submitted
17/01/2021
Date registered
10/03/2021
Date last updated
20/03/2023
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of middle meningeal artery embolisation as post-operative adjunct treatment for chronic subdural haematoma in adult patients
Scientific title
The efficacy of middle meningeal artery embolisation as post-operative adjunct treatment for unstable chronic subdural haematoma in adult patients
Secondary ID [1] 303197 0
None
Universal Trial Number (UTN)
U1111-1254-3825
Trial acronym
Linked study record
This study is linked to another study that is currently registered ACTRN12621000202864
-The other study is investigating the role of MMA embolization as a primary treatment for stable patients with chronic subdural haematoma

Health condition
Health condition(s) or problem(s) studied:
Chronic subdural haematoma 320329 0
Condition category
Condition code
Surgery 318245 318245 0 0
Surgical techniques
Neurological 318246 318246 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional group:
Arm 1: Middle meningeal embolization following emergency surgical evacuation
-Materials: Liquid embolic agent
-Procedure: MMA embolization following emergency surgery (During the same admission, within 7 days ideally)
-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] 319499 0
Treatment: Surgery
Comparator / control treatment
Arm 2: observation only following emergency surgical evacuation
-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] 326225 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] 326225 0
Outpatient follow-up with CT Scan at 6 weeks, 3 months and 6 months post-procedure
Secondary outcome [1] 390593 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] 390593 0
For intervention group (Arm 1): At 6 weeks, 3 months and 6 months post-procedure
For control (Arm 2): At 6 weeks, 3 months and 6 months post initial surgical evacuation
Secondary outcome [2] 390594 0
Hospital length of stay
-Assessed via reviewing of hospital record
Timepoint [2] 390594 0
from admission until hospital discharge
Secondary outcome [3] 390595 0
-Modified Rankin Scale
Timepoint [3] 390595 0
On admission
Upon discharge
At 6 weeks, 3 months and 6 months follow-ups post-procedure
Secondary outcome [4] 392275 0
Infection and wound dehiscence
Timepoint [4] 392275 0
Wound review during admission, upon discharge and at 6 weeks and 3 months post-procedure
Secondary outcome [5] 392277 0
Procedure related complications including neurological deficits, seizures, stroke and Death
Timepoint [5] 392277 0
Clinical review during admission, upon discharge and outpatient review at 6 weeks, 3months and 6 months post-procedure
Secondary outcome [6] 392278 0
Non-procedure related complications including DVT, PE, MI
-These complications will be assessed clinically
Timepoint [6] 392278 0
During admission
Upon discharge
6 weeks, 3 months and 6 months post-procedure

Eligibility
Key inclusion criteria
Patient aged 18 or above with a diagnosis of chronic subdural haematoma. A patient is considered unstable (i.e. requiring emergency surgical evacuation on admission) if they fit one of more of the following criteria:
1. GCS <= 12
2. Lateralised weakness if present with power < 4/5
3. Other neurological deficits including seizures, dysphasia and gait disturbance
Minimum age
18 Years
Maximum age
No limit
Sex
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.
Masking / blinding
Open (masking not 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
Arm 1: the anticipated recurrence rate following emergency surgical evacuation and post-operative MMA embolisation is 3%

Arm 2: the anticipated recurrence rate following emergency surgical evacuation without post-operative MMA embolisation is 30%

The required sample size in each group is estimated to be 36 patients for alpha = 0.05 and power = 90%.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2021
Actual
1/05/2022
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
36
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 18438 0
The Canberra Hospital - Garran
Recruitment hospital [2] 24307 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 32545 0
2605 - Garran
Recruitment postcode(s) [2] 39859 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 307598 0
Hospital
Name [1] 307598 0
The Canberra Hospital
Country [1] 307598 0
Australia
Funding source category [2] 307599 0
Commercial sector/Industry
Name [2] 307599 0
Terumo Microvention
Country [2] 307599 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
77
Yamba Drive
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 308292 0
None
Name [1] 308292 0
None
Address [1] 308292 0
None
Country [1] 308292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307653 0
ACT Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 307653 0
PO Box 11 Woden ACT 2606, Canberra Hospital, Building 10 Level 6
Ethics committee country [1] 307653 0
Australia
Date submitted for ethics approval [1] 307653 0
07/09/2020
Approval date [1] 307653 0
01/04/2021
Ethics approval number [1] 307653 0
2020.ETH.00157

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.
-Unstable cSDH patients who require urgent surgical evacuation on admission will be randomly allocated to receive post-operative MMA embolisation or observation (current standard treatment) during the same admission
-We aim to demonstrate that post-operative MMA embolisation can reduce the rate of recurrent cSDH requiring repeat surgical evacuation
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108018 0
Dr Peter Mews
Address 108018 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran, ACT 2605
Country 108018 0
Australia
Phone 108018 0
+61 2 5124 4080
Fax 108018 0
Email 108018 0
[email protected]
Contact person for public queries
Name 108019 0
Dr Alexander Lam
Address 108019 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 108019 0
Australia
Phone 108019 0
+61 2 5124 4080
Fax 108019 0
Email 108019 0
[email protected]
Contact person for scientific queries
Name 108020 0
Dr Alexander Lam
Address 108020 0
Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 108020 0
Australia
Phone 108020 0
+61 2 5124 4080
Fax 108020 0
Email 108020 0
[email protected]

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 - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10267Study protocol    381240-(Uploaded-17-01-2021-17-33-48)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe efficacy of postoperative middle meningeal artery embolization on chronic subdural hematoma - A multicentered randomized controlled trial.2023https://dx.doi.org/10.25259/SNI_208_2023
N.B. These documents automatically identified may not have been verified by the study sponsor.