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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] 281942 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Subdural Haematomas 288352 0
Condition category
Condition code
Neurological 288704 288704 0 0
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] 286504 0
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] 288847 0
Recurrence rate of chronic subdural haematomas
Timepoint [1] 288847 0
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] 301135 0
NIL
Timepoint [1] 301135 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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)
QLD

Funding & Sponsors
Funding source category [1] 286722 0
Hospital
Name [1] 286722 0
Townsville Hospital Private Practice Trust Fund
Address [1] 286722 0
100 Angus Smith Drive
Townsville
QLD 4814
Country [1] 286722 0
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] 285495 0
None
Name [1] 285495 0
None
Address [1] 285495 0
Country [1] 285495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288794 0
The Townsville Hospital Human Research Ethics Committee
Ethics committee address [1] 288794 0
100 Angus Smith Drive
Douglas QLD 4814
Ethics committee country [1] 288794 0
Australia
Date submitted for ethics approval [1] 288794 0
Approval date [1] 288794 0
25/05/2012
Ethics approval number [1] 288794 0
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 37790 0
Dr Laurence Marshman
Address 37790 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 37790 0
Australia
Phone 37790 0
+61 7 4433 1111
Fax 37790 0
Email 37790 0
laurence_marshman@health.qld.gov.au
Contact person for public queries
Name 37791 0
Mr Kelvin Robertson
Address 37791 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 37791 0
Australia
Phone 37791 0
+61 7 4433 1111
Fax 37791 0
Email 37791 0
kelvin_robertson@health.qld.gov.au
Contact person for scientific queries
Name 37792 0
Dr Laurence Marshman
Address 37792 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 37792 0
Australia
Phone 37792 0
+61 7 4433 1111
Fax 37792 0
Email 37792 0
laurence_marshman@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results