Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000201471
Ethics application status
Not required
Date submitted
8/02/2016
Date registered
16/02/2016
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes related to symptomatic vasospasm after aneurysmal subarachnoid haemorrhage before-and-after the introduction of neuro-interventional radiology service
Scientific title
Outcomes related to symptomatic vasospasm after aneurysmal subarachnoid haemorrhage before-and-after the introduction of neuro-interventional radiology service
Secondary ID [1] 288239 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subarachnoid haemorrhage 297170 0
Condition category
Condition code
Neurological 297386 297386 0 0
Other neurological disorders
Stroke 297823 297823 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single center retrospective before-and-after cohort study. The primary aim is to to evaluate the difference in unfavorable neurological outcomes, as assessed by modified Rankin Scale (mRS) >=3, among all consecutive Intensive Care Unit (ICU) patients, who were admitted with Subarachnoid Haemorrhage (SAH) and suspected to have symptomatic vasospasm (SV), 30 months before and 30 months after the introduction of the Neuro-Interventional radiology (NIR) service at our university-affiliated tertiary-care referral hospital. The required data will first be collected for the period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase). All consecutive patients who would be deemed eligible according to the following criteria would be enrolled.

mRS scores and follow-up are planned to be recorded at or closest to 6 months after the date of ictus.

The NIR service at John Hunter Hospital was introduced in January 2103. Before the service was introduced, patients with SAH were managed by the Neuro-Surgery service either expectantly, having the aneurysm coiled in theatre or transferred to Royal North Shore Hospital for management of complex aneurysms and complications like SV.
Since the introduction of the NIR service, patients have access to angioplasty, coiling and intra-arterial calcium channel blockers when indicated.
Intervention code [1] 293526 0
Diagnosis / Prognosis
Comparator / control treatment
The primary aim is to evaluate the difference in unfavorable neurological outcomes, as assessed by mRS >=3, among all consecutive Intensive Care Unit (ICU) patients, who were admitted with SAH and suspected to have SV, 30 months before and 30 months after the introduction of the Neuro-Interventional radiology (NIR) service at our university-affiliated tertiary-care referral hospital.
Required data will be collected retrospectively for the 1 Jul 2010 to 30 Dec 2012 period (for the pre-NIR group or 'before' phase) and then for the 1 Jan 2013 to 30 June 2015 period (for the NIR group or 'after' phase).
Control group
Historical

Outcomes
Primary outcome [1] 297070 0
To evaluate the difference in unfavorable neurological outcomes, as assessed by mRS >=3, among all consecutive Intensive Care Unit (ICU) patients, who were admitted with SAH and suspected to have Symptomatic Vasospasm (SV).
Timepoint [1] 297070 0
30 months before and 30 months after the introduction of the Neuro-Interventional radiology (NIR) service at our university-affiliated tertiary-care referral hospital.
Time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
mRS data will be recorded at or closest to 6 months after the date of ictus.
Secondary outcome [1] 319957 0
To assess whether the ‘after’ phase was associated with lower incidence of SV as compared to that during the ‘before’ phase. Data to be collected from hospital records.
Timepoint [1] 319957 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [2] 319958 0
To assess whether the time spent with unsecured aneurysm prior to the onset of SV, have any relationship with MRS scores and mortality. Data to be collected from hospital records.
Timepoint [2] 319958 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [3] 319959 0
To assess if there is any difference in the time to develop SV between the two phases. Data to be collected from hospital records.
Timepoint [3] 319959 0
Time from onset of SAH to documented SV in the notes.
Secondary outcome [4] 319960 0
To compare World Federation of Neurosurgical Societies (WFNS) grade , Prognosis on Admission of Aneurysmal Subarachnoid Haemorrhage (PAASH) score , Fisher score and Claassen scale as predictors of neurological outcomes assessed by mRS.
Timepoint [4] 319960 0
WFNS, PAASH, Fisher score and Claassen scale completed at time of admission to tertiary care centre, and neurological outcome assessed by mRS scores available at or closest to 6 months after the date of ictus.
Secondary outcome [5] 320778 0
To assess whether the ‘after’ phase was associated with lower incidence of cerebral infarcts as compared to that during the ‘before’ phase. Data to be collected from hospital records.
Timepoint [5] 320778 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [6] 320779 0
To assess whether the ‘after’ phase was associated with lower mortality as compared to that during the ‘before’ phase. Data to be collected from hospital records.
Timepoint [6] 320779 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [7] 320780 0
To assess whether the ‘after’ phase was associated with shorter length of ICU admission as compared to that during the ‘before’ phase. Data to be collected from hospital records.
Timepoint [7] 320780 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [8] 320781 0
To assess whether the ‘after’ phase was associated with shorter length of hospital admission as compared to that during the ‘before’ phase. Data to be collected from hospital records.
Timepoint [8] 320781 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).
Secondary outcome [9] 320782 0
To assess whether the time spent in non-critical care areas prior to the onset of SV, have any relationship with MRS scores and mortality. Data to be collected from hospital records.
Timepoint [9] 320782 0
Data collected for eligible patients admitted in the time period between 1 Jul 2010 to 30 Dec 2012 (the ‘before’ phase), and then for the period between 1 Jan 2013 to 30 June 2015 (the ‘after’ phase).

Eligibility
Key inclusion criteria
Adult (18 years or above) ICU patients
Diagnosis of SAH confirmed on a CT scan with suspected SV.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Died or treatment limitations within 3 days of hospitalisation
Died within 3 days of the initial rupture of the aneurysm
Non-aneurysmal causes of SAH (e.g. trauma, arterio-venous malformation)

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Standard descriptive analysis of categorical variables (frequencies and percents) with effect sizes modeled using logistic regression.
The Modified Rankin Score will be used to measure pre- and post- introduction of NIR service.
Significance level is chosen to be <0.05.
Statistical analysis will be performed using Stata 13.1 (College Station, Texas).

Previous studies have reported an 18% incidence of SV among SAH patients who had an uncomplicated course of treatment. Endovascular treatment of vasospasm can reverse angiographic vasospasm by 96% and is reported to improve neurologic outcomes in 60% to 80% of these patients. Accordingly, with an estimated baseline SV incidence rate of 20%, we would require a sample size of 75 patients per phase to demonstrate 75% relative risk reduction in the proportion of unfavourable neurological outcomes. This sample size would provide 80% power at a two-sided p value of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/02/2016
Actual
8/02/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
150
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5059 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 292700 0
Self funded/Unfunded
Name [1] 292700 0
Jorge Pena Mogollon
Country [1] 292700 0
Australia
Primary sponsor type
Individual
Name
Jorge Pena Mogollon
Address
John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 291427 0
None
Name [1] 291427 0
Address [1] 291427 0
Country [1] 291427 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Hypothesis: We hypothesize that the introduction of NIR service at our hospital is associated with a significant reduction in unfavorable neurological outcomes related to SV among patients with SAH. Our secondary hypothesis is that there is an association between clinical outcomes and the length of ICU stay prior to the surgical or endovascular management of SAH and that prior to suspected SV.

Aims: Our primary aim is to compare differences in neurological outcomes, among patients who were admitted with SAH and were suspected to have SV, during a period of 30 months before-and-after the introduction of NIR service at a university-affiliated tertiary referral hospital.
Primary objective: To assess and compare modified Rankin scores (mRS), at/or closest to 6 months after hospital discharge, among patients with SAH and suspected SV during a period of 30 months before and 30 months after the introduction of NIR service at our hospital.

Secondary objectives:
* To assess whether the ‘after’ phase was associated with lower incidence of SV, lower incidence of cerebral infarcts, shorter length of hospital admission, and lower mortality as compared to that during the ‘before’ phase.
* To assess whether the time spent with unsecured aneurysm, or the time spent in non-critical care areas prior to the onset of SV have any relationship with mRS scores and mortality.

Methods: This is a retrospective before-and-after study at a multidisciplinary academic ICU at John Hunter Hospital, Newcastle. The study will be conducted over a period of 12 months during which the required data will be collected retrospectively for the 1 Jul 2010 to 30 Dec 2012 period and then for the 1 Jan 2013 to 30 June 2015 period. All consecutive eligible patients admitted during the two periods will be enrolled in the study. Besides demographics, severity scores and clinical outcomes, the study will also collect data related to process-of-care during the two periods.

Significance: The health and financial burden of long-term complications due to SV among patients with SAH are substantial. This observational study will inform the overall clinical outcomes for these patients in our practice. This may help us benchmark our clinical outcomes against those reported in international studies. This baseline data might also be useful to design an interventional trial investigating strategies to improve quality of care delivered to this patient group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62474 0
Dr Jorge Pena Mogollon
Address 62474 0
John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 62474 0
Australia
Phone 62474 0
+61404180627
Fax 62474 0
Email 62474 0
andrespena9@gmail.com
Contact person for public queries
Name 62475 0
Dr Jorge Pena Mogollon
Address 62475 0
John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 62475 0
Australia
Phone 62475 0
+61404180627
Fax 62475 0
Email 62475 0
andrespena9@gmail.com
Contact person for scientific queries
Name 62476 0
Dr Jorge Pena MOgollon
Address 62476 0
John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 62476 0
Australia
Phone 62476 0
+61404180627
Fax 62476 0
Email 62476 0
andrespena9@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes World Neurosurgery, Volume 113, May 2018, Pages e2... [More Details]

Documents added automatically
No additional documents have been identified.