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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12613000175774 |
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Date of registration:
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12/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study to compare surgery for chronic subdural haematoma with and without corticosteroids.
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Scientific title:
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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). |
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Date of first enrolment:
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29/11/2013 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12613000175774.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
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Phase:
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Phase 2 / Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mr Kelvin Robertson
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Address:
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The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Australia |
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Telephone:
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+61 7 4433 1111 |
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Email:
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kelvin_robertson@health.qld.gov.au |
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Affiliation:
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Name:
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Dr Laurence Marshman
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Address:
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The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Australia |
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Telephone:
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+61 7 4433 1111 |
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Email:
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laurence_marshman@health.qld.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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).
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Neurological - Other neurological disorders
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Chronic Subdural Haematomas;
Chronic Subdural Haematomas
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Intervention(s)
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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.
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Primary Outcome(s)
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Recurrence rate of chronic subdural haematomas[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.]
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Secondary Outcome(s)
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NIL[NIL]
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Source(s) of Monetary Support
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Townsville Hospital Private Practice Trust Fund
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Ethics review
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Status: Approved
Approval date:
Contact:
The Townsville Hospital Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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