ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000175774

Ethics application status

Approved

Date submitted

12/02/2013

Date registered

12/02/2013

Date last updated

24/01/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

A study to compare surgery for chronic subdural haematoma with and without corticosteroids.

Scientific title

Prospective randomized clinical study of corticosteroids with surgery compared to surgery alone in patients with chronic subdural haematomas to reduce the reoccurence of chronic subdural haematomas (placebo-controlled double-blind study).

Secondary ID [1]

NIL

Universal Trial Number (UTN)

NIL

Trial acronym

NIL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Subdural Haematomas

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Surgery with corticosteroid (dexamethasone) oral capsule administered 4mg four times a day for 3 days and then reduced to 2mg three times a day for a maximum of 2 weeks. First dose is administered after onset of general anesthesia.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Surgery with Placebo capsules administered in the same process as the active group (4mg QID for 3 days then reduce to 2mg TDS for maximum of 2 weeks). Placebo treatment is initiated at the start of general anesthesia.

Control group

Placebo

Outcomes

Primary outcome [1]

Recurrence rate of chronic subdural haematomas

Timepoint [1]

Occurrence of signs and symptoms attributable to an ipsilateral chronic subdural haematoma seen on imaging (CT or MRI) within 6 months of the original drainage procedure.

Secondary outcome [1]

NIL

Timepoint [1]

NIL

Eligibility

Key inclusion criteria

All patients aged 18yrs or more with demonstrated chronic subdural haematoma (CSDH) (either on CT or MRI or both) that is considered by the admitting neurosurgical team to be the cause of the patient's presenting symptoms and/or signs, and to be amenable to neurosurgical management will be considered suitable for study. All patients with diabetes mellitus will be discussed with an endocrinologist prior to commencing corticosteroid (CS).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children less than 18yrs will be excluded because the nature of CSDH in this group is entirely different to that observed in adults. Pregnant women will be excluded because CS can cause congenital malformations. Patients with a history of psychosis will be excluded because CS can provoke relapses.

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)

This is a double-blind study with patients receiving identical matching capsules of either dexamethasone or placebo. The interventions are sealed in sequentially numbered identical containers according to the allocation sequence. To ensure allocation concealment, the contents (powders) of the capsules will also be identical in texture, odor and colour.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation is by a formulated permuted block with varying block sizes in a 1:1 ratio.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2013

Actual

29/11/2013

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Townsville Hospital Private Practice Trust Fund

Address [1]

100 Angus Smith Drive
Townsville
QLD 4814

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Townsville Hospital

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Hospital Human Research Ethics Committee

Ethics committee address [1]

100 Angus Smith Drive
Douglas QLD 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/05/2012

Ethics approval number [1]

HREC/11/QTHS/189

Summary

Brief summary

Corticosteroids (CS) are anti inflammatory agents and are frequently used in neurosurgical and neurological
practice: they are a routine adjunct to surgery in patients with brain tumours worldwide.

Several clinical studies have also demonstrated the utility and safety of CS as an alternative to surgery with CSDH: however, most studies have merely compared CS as ‘medical versus surgical management’. Only one study has directly compared the effects of CS as an adjunct to surgery: although a null effect was observed, the ‘surgery alone’ group consisted of only 13 subjects; and the study was not randomised.

We propose to perform the first prospective, randomized, placebo-controlled double-blind clinical study of surgery for CSDH with and without corticosteroids as an adjunct. We aim to see whether surgery plus CS might reduce operative recurrences, in-patient stay and mortality.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Laurence Marshman

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

[email protected]

Contact person for public queries

Name

Kelvin Robertson

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

[email protected]

Contact person for scientific queries

Name

Laurence Marshman

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Mebberson K, Colditz M, Marshman L, Thomas P, Mitc... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	History and current progress of chronic subdural hematoma.	2021	https://dx.doi.org/10.1016/j.jns.2021.118066

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically