ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Surgical techniques

Neurological

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]

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]

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]

Outpatient follow-up with CT Scan at 6 weeks, 3 months and 6 months

Secondary outcome [1]

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]

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]

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]

From admission until hospital discharge

Secondary outcome [3]

Hospital length of stay
-Assessed via reviewing of hospital record

Timepoint [3]

from admission until hospital discharge

Secondary outcome [4]

Modified Rankin Scale

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

8/03/2021

Actual

Date of last participant enrolment

Anticipated

31/01/2022

Actual

Date of last data collection

Anticipated

31/07/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Canberra Hospital

Address [1]

Yamba Drive, Garran, ACT 2605

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Terumo Microvention

Address [2]

Level 29, Australia Square, 264 George Street, Sydney, NSW 2000, Australia, Attn: Kevin Culpan

Country [2]

Australia

Primary sponsor type

Hospital

Name

The Canberra Hospital

Address

Yamba Drive, Garran, ACT 2605

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee (HREC)

Ethics committee address [1]

PO Box 11 Woden ACT 2606, Canberra Hospital, Building 10 Level 6

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/09/2020

Approval date [1]

Ethics approval number [1]

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

Dr Peter Mews

Address

Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran, ACT 2605

Country

Australia

Phone

+61 2 5124 4080

Fax

Peter.Mews@act.gov.au

Contact person for public queries

Name

Alexander Lam

Address

Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran, ACT 2605

Country

Australia

Phone

+61 2 5124 4080

Fax

Neurosurgery@act.gov.au

Contact person for scientific queries

Name

Alexander Lam

Address

Department of Neurosurgery
The Canberra Hospital
Yamba Drive
Garran ACT 2605

Country

Australia

Phone

+61 2 5124 4080

Fax

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8353	Study protocol	.			.	380090-(Uploaded-18-10-2020-15-22-48)-Study-related document.docx

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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