Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001379202
Ethics application status
Approved
Date submitted
14/08/2018
Date registered
16/08/2018
Date last updated
16/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing delays in aneurysmal subarachnoid haemorrhage
Scientific title
Reducing delays in aneurysmal subarachnoid haemorrhage: a retrospective data study
Secondary ID [1] 295512 0
None
Universal Trial Number (UTN)
U1111-1217-1142
Trial acronym
REDDISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aneurysmal Subarachnoid Haemorrhage 308778 0
Stroke 308779 0
Condition category
Condition code
Stroke 307715 307715 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will audit the medical records of first-ever aneurysmal subarachnoid haemorrhage occurring within the referral networks of two tertiary hospitals between 2010 and 2016. The retrospective study design is due to the low incidence of aSAH (~9/100,000 people per year).
Intervention code [1] 301829 0
Early Detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306701 0
To quantify the time delays in the treatment of aneurysmal subarachnoid haemorrhage for patients across Tasmania and South-East Victoria. This will be assessed with an audit of admission and treatment times recorded in medical records.
Timepoint [1] 306701 0
Retrospective data from 2010 to 2016
Secondary outcome [1] 349300 0
Discharge destination as recorded in medical records and linked with the National Death Index: home, another hospital, nursing home, rehabilitation, death.
Timepoint [1] 349300 0
Retrospective data 2010-2016
Secondary outcome [2] 349301 0
Functional Independence Measure scores will be extracted from an audit of medical records both at discharge from acute hospital and discharge from rehabilitation. This data will be cross-checked with the AROC database (The Australasian Rehabilitation Outcomes Centre). This is the national rehabilitation medicine clinical registry of Australia and New Zealand
Timepoint [2] 349301 0
Retrospective data 2010 to 2016

Eligibility
Key inclusion criteria
We will include cases of first-ever aneurysmal subarachnoid haemorrhage occurring within the referral networks of two tertiary hospitals between 2010 and 2016.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People who have experienced a subarachnoid haemorrhage that has not occurred secondary to the rupture of an aneurysm, including individuals with arteriovenous malformations or haemorrhages secondary to infectious and traumatic events, and or extensions of ICH, where the primary cause has not been aneurysmal.
2. In Tasmania only, Individuals will also be excluded if their usual residence was not Tasmania.
3. Individuals re-presenting to hospital following for adverse events following the securement of their aneurysm, unless a second aneurysm had ruptured during the study period.
4. Aneurysm rupture occurred outside of the study period 1/1/2010 to 31/12/2016

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
We will calculate the mean (± standard deviation, SD) and median (interquartile range, IQR) delays in hours between the onset of symptoms and receipt of treatment with either neurosurgical clipping or endovascular coiling to secure the aneurysm. We will also calculate times from onset to: (1) call for ambulance, (2) arrival at first emergency department, (3) arrival at treating hospital (if transferred) and (4) first neuroimaging.

We will examine predictors of the delay between the onset of symptoms and treatment as a continuous outcome using linear mixed models (with transformation of delays if necessary) to account for clustering within the treating hospital. Results will be presented as mean differences in hours (± 95% CI).

We will estimate the associations with the treatment delay using Cox proportional hazards modelling (hazard of death/survival), log binomial regression (discharge destination, any vs no complications, any vs no discharge home) and ordinal models (total number of complications) with account for clustering by hospital in each analysis. We will model non-linearity using fractional polynomials, and use calculus or change-point analysis to identify cut-points for ‘early’ treatment and confirm those reported in the literature (e.g. with in 24 hours).

We will give careful consideration to the role of factors that might confound, mediate or moderate the analyses for hypotheses 2 and 3, particularly the year of aSAH (to account for any secular changes) and the severity of the aSAH using the WFNS score. The CI team, particularly CI Blizzard, has a wealth of experience in contemporary methods for dealing with missing data and the potential bias these introduce using techniques such as multiple imputation and inverse probability weighting.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/07/2018
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
1036
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 11411 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 11412 0
North West Regional Hospital - Burnie
Recruitment hospital [3] 11413 0
Launceston General Hospital - Launceston
Recruitment hospital [4] 11414 0
Mersey Community Hospital - Latrobe
Recruitment hospital [5] 11415 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 11463 0
Dandenong Hospital - Dandenong
Recruitment hospital [7] 11464 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [8] 11465 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 23324 0
7000 - Hobart
Recruitment postcode(s) [2] 23325 0
7320 - Burnie
Recruitment postcode(s) [3] 23326 0
7250 - Launceston
Recruitment postcode(s) [4] 23327 0
7307 - Latrobe
Recruitment postcode(s) [5] 23328 0
3168 - Clayton
Recruitment postcode(s) [6] 23483 0
3175 - Dandenong
Recruitment postcode(s) [7] 23484 0
3165 - East Bentleigh
Recruitment postcode(s) [8] 23485 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 300097 0
Government body
Name [1] 300097 0
NHMRC
Country [1] 300097 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
17 Liverpool St, Hobart TAS 7000
Menzies Research Institute Tasmania
Country
Australia
Secondary sponsor category [1] 299496 0
University
Name [1] 299496 0
Monash University
Address [1] 299496 0
Scenic Blvd & Wellington Road, Clayton VIC 3800
Monash University
Country [1] 299496 0
Australia
Other collaborator category [1] 280235 0
Hospital
Name [1] 280235 0
Monash Health
Address [1] 280235 0
246 Clayton Rd, Clayton VIC 3168
Monash Medical Centre
Country [1] 280235 0
Australia
Other collaborator category [2] 280252 0
Government body
Name [2] 280252 0
Tasmanian Health Service
Address [2] 280252 0
Department of Health and Human Services
GPO Box 125
HOBART TAS 7001
Country [2] 280252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300941 0
Tasmania Health & Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 300941 0
University of Tasmania
Building 1, First Floor, 301 Sandy Bay Road
Hobart TAS 7001
Ethics committee country [1] 300941 0
Australia
Date submitted for ethics approval [1] 300941 0
01/01/2018
Approval date [1] 300941 0
03/05/2018
Ethics approval number [1] 300941 0
Ethics Ref: H0014563
Ethics committee name [2] 300942 0
Monash Health HREC
Ethics committee address [2] 300942 0

Research Support Services Monash Health Level 2, I Block Monash Medical Centre 246 Clayton Road Clayton Victoria 3168
Ethics committee country [2] 300942 0
Date submitted for ethics approval [2] 300942 0
05/02/2018
Approval date [2] 300942 0
22/02/2018
Ethics approval number [2] 300942 0
Monash Health Ref: RES-18-0000-036A

Summary
Brief summary
Aneurysmal subarachnoid haemorrhage (aSAH) is a rare but devastating form of stroke caused by a ruptured brain aneurysm that kills at least 30% of sufferers within 1 month. Up to 50% of people with aSAH will experience delays greater than 24 hours between onset of aSAH and receiving treatment. This study aims to quantify the time delays in treatment of aSAH for patients across Tasmania and South-East Victoria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85358 0
Dr Seana Gall
Address 85358 0
Menzies Institute for Medical Research, University of Tasmania
Private Bag 23, Hobart TAS 7000
Country 85358 0
Australia
Phone 85358 0
+61 3 6226 4728
Fax 85358 0
Email 85358 0
[email protected]
Contact person for public queries
Name 85359 0
Ms Gemma Kitsos
Address 85359 0
Menzies Institute for Medical Research, University of Tasmania
Private Bag 23, Hobart TAS 7000
Country 85359 0
Australia
Phone 85359 0
+61 431 016 587
Fax 85359 0
Email 85359 0
[email protected]
Contact person for scientific queries
Name 85360 0
Dr Seana Gall
Address 85360 0
Menzies Institute for Medical Research, University of Tasmania
Private Bag 23, Hobart TAS 7000
Country 85360 0
Australia
Phone 85360 0
+61 3 6226 4728
Fax 85360 0
Email 85360 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23664Study protocol  [email protected]

Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4090Plain language summaryNo Data collection is complete but results are not ye... [More Details]

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