Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001035213
Ethics application status
Approved
Date submitted
14/06/2018
Date registered
20/06/2018
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Date results information initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of the MAnagement of Systolic blood pressure during Thombectomy by
Endovascular Route for acute ischaemic STROKE (MASTERSTROKE)
Scientific title
A pragmatic, prospective, multi-centre, double-blind randomised controlled pilot trial of the MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischaemic STROKE (MASTERSTROKE)
Secondary ID [1] 295205 0
ADHB 7773
Universal Trial Number (UTN)
Trial acronym
MASTERSTROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308341 0
Thrombectomy 308342 0
Condition category
Condition code
Stroke 307344 307344 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Augmented - maintain SBP at 170mmHg +/-10mmHg from the onset of anaesthesia until recanalization. Maintenance of blood pressure is done at the discretion of the treating anaesthetist; according to New Zealand Society of Anaesthetists 2016 Guidelines
Intervention code [1] 301543 0
Treatment: Other
Comparator / control treatment
Standard’ – maintain SBP at 140mmHg +/-10mmHg from the onset of anaesthesia until recanalization utlising all normal anaesthesia blood pressure management.
Control group
Active

Outcomes
Primary outcome [1] 306303 0
Functional Recovery as determined by a modified Rankin Score scores of 0, 1 or 2 at 3 months.
Timepoint [1] 306303 0
Day 90 Post thrombectomy
Secondary outcome [1] 348128 0
Neurological improvement defined by National Institute of Health Stroke Scale (NIHSS)
Timepoint [1] 348128 0
24 hours post thrombectomy
Secondary outcome [2] 348129 0
all-cause mortality confirmed by patient follow-up and clinical note review.
Timepoint [2] 348129 0
90 days post thrombectomy
Secondary outcome [3] 348198 0
Proportion of patients with intra-procedural complications (vessel perforation, dissection, devicerelated
complications, haemodynamic and airway complications, reperfusion syndrome, thrombus
migration or restenosis, seizures during treatment, groin haematoma)
Timepoint [3] 348198 0
From randomization until day 90
Secondary outcome [4] 348199 0
Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment,
associated with an increase of NIHSS of at least 4 points from baseline), including :
subarachnoid haemorrhage associated with clinical symptoms
symptomatic intracerebral haemorrhage (parenchymal haematoma type 2).
Timepoint [4] 348199 0
From randomisation until 36 hours post treatment.

Eligibility
Key inclusion criteria
Functionally independent patients (mRS 0 – 2) diagnosed with anterior circulation stroke (internal carotid artery or proximal M1 or M2 segment of middle cerebral artery)
presenting within six hours of stroke onset who fulfil current guidelines for thrombectomy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Rescue’ procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass.
• Prestroke
mRS score of 3 (indicating previous disability)
• Contraindication to imaging with contrast agents
• Any terminal illness with expected survival less than 1 year
• Pregnant women
• Any medical condition where there is a contraindication to either treatment arm, or haemodynamic targeting will be problematic eg. severe aortic regurgitation

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Methods
Sample size is 30 if the trial remains a single-centre pilot and 50 if Wellington and Christchurch Hospitals participate. This is consistent with previous pilot trial experience and published guidelines and is estimated to be the number recruited over a four-month period if 50% of eligible patients are recruited. Primary analyses will be by intention to treat (ITT). Feasibility outcomes will be described with simple descriptive statistics. Inferential statistics for the primary and secondary outcomes will be with chi-squared testing. Any continuous data will be transformed as appropriate, before Students t-testing. P-values will be reported when appropriate. The primary and secondary outcomes will report the event rate and 95% confidence interval (CI).

Sample size for a large trial will be based on the proportion of patients experiencing good late neurological outcomes (mRS 0-2 at 3 months). Expected sample sizes based on initial proportions of good outcome of 54% (current ADHB value), 62%, and 71% (EXTEND-IA values, a trial with selection criteria favouring better overall outcome than current clinical inclusion criteria), and absolute treatment effects of 10%, 8% and 5%. For context, the absolute treatment effect in recategorization to good outcome was 20% in the pooled trial meta-analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2018
Actual
24/06/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
5/10/2018
Date of last data collection
Anticipated
1/10/2019
Actual
9/01/2019
Sample size
Target
50
Accrual to date
Final
51
Recruitment outside Australia
Country [1] 10562 0
New Zealand
State/province [1] 10562 0
Auckland

Funding & Sponsors
Funding source category [1] 299789 0
Charities/Societies/Foundations
Name [1] 299789 0
Auckland District Health Board Charitable Trust
Country [1] 299789 0
New Zealand
Funding source category [2] 299790 0
Other Collaborative groups
Name [2] 299790 0
ANZCA Clinical Trials Network Executive
Country [2] 299790 0
Australia
Primary sponsor type
Individual
Name
Dr Douglas Campbell
Address
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 299139 0
None
Name [1] 299139 0
Address [1] 299139 0
Country [1] 299139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300676 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300676 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300676 0
New Zealand
Date submitted for ethics approval [1] 300676 0
21/03/2018
Approval date [1] 300676 0
29/05/2018
Ethics approval number [1] 300676 0
18/NTB/55

Summary
Brief summary
Internationally stroke ranks fifth among all causes of death and is considered the second leading healthcare burden. Over the last 5 years endovascular thrombectomy (clot retrieval) has been effective for the treatment of acute large vessel ischaemic stroke, with significant reductions in long term patient disability compared to standard
treatment. However, there is minimal definitive guidance on the importance of haemodynamic management during the procedure, which may be linked to poor functional recovery. The brain is especially vulnerable to BP variation during the acute stroke period due to ischaemia from the clot, reperfusion injury and impaired cerebral autoregulation. Theoretically, arterial hypertension may be detrimental as it leads to encephalopathy, cerebral oedema and haemorrhagic transformation of ischaemic tissue. Conversely, arterial hypotension may lead to hypoperfusion of the ischaemic brain and other organs. Current evidence is limited to large observational studies. Auckland DHB is one of 3 DHBs around New Zealand to provide a 24 hour thrombectomy service. This pilot study will examine the effect of two systolic blood pressures (SBP) management arms during clot retrieval on outcomes in patients with acute ischaemic stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84434 0
Dr Carolyn Deng
Address 84434 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 84434 0
New Zealand
Phone 84434 0
+6493757095
Fax 84434 0
+6493754578
Email 84434 0
[email protected]
Contact person for public queries
Name 84435 0
Ms Davina Mcallister
Address 84435 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 84435 0
New Zealand
Phone 84435 0
+6493757095
Fax 84435 0
+6493754378
Email 84435 0
[email protected]
Contact person for scientific queries
Name 84436 0
Dr Doug Campbell
Address 84436 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 84436 0
New Zealand
Phone 84436 0
+6493757095
Fax 84436 0
+6493754378
Email 84436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no decision has been reached by the steering committee around what data may potentially available in the public domain.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot randomised controlled trial of the management of systolic blood pressure during endovascular thrombectomy for acute ischaemic stroke.2020https://dx.doi.org/10.1111/anae.14940
N.B. These documents automatically identified may not have been verified by the study sponsor.