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Trial registered on ANZCTR


Registration number
ACTRN12619001274167
Ethics application status
Approved
Date submitted
13/08/2019
Date registered
16/09/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischaemic STROKE: the MASTERSTROKE trial
Scientific title
A pragmatic, multi-centre, patient and assessor-blinded, parallel group, randomised controlled trial (RCT) comparing a ‘standard’ and ‘augmented’ systolic blood pressure strategy during general anaesthesia for endovascular thrombectomy in acute ischaemic stroke
Secondary ID [1] 298929 0
ADHB 8173
Universal Trial Number (UTN)
Trial acronym
MASTERSTROKE
Linked study record
ACTRN12618001035213 - Masterstroke Pilot study provided the feasibility information and evaluation of the outcomes of the current record.

Health condition
Health condition(s) or problem(s) studied:
Stroke 313920 0
Endovascular Thrombectomy 313921 0
Condition category
Condition code
Stroke 312328 312328 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Augmented - Maintain Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg from the onset of anaesthesia until recanalization.

This is a pragmatic, comparative effectiveness study. The techniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. all usual intra-procedural anaesthetic records and clot retrieval documentation will be collected and analyses of these records will be done by an unblinded study member to survey protocol adherence during the course of the study.
Intervention code [1] 315209 0
Treatment: Other
Comparator / control treatment
Standard - Maintain Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg from the onset of anaesthesia until recanalization utilizing all normal anaesthesia blood pressure management.

This is a pragmatic, comparative effectiveness study. Techniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. All usual intraprocedural anaesthetic records and clot retrieval documentation will be collected and analyses of these records will be done by an unblinded study member to survey protocol adherence during the course of the study.
Control group
Active

Outcomes
Primary outcome [1] 320956 0
Change in disability measured by ordinal shift in the modified Rankin Score assessed at day 90 and assessed by ordinal shift analysis.
Timepoint [1] 320956 0
90 days Post Thrombectomy
Secondary outcome [1] 373497 0
Independent functional outcome as determined by a modified Rankin Score of 0,1,or 2 at 90 Days
Timepoint [1] 373497 0
90 days Post Thrombectomy
Secondary outcome [2] 373498 0
The number of days a participant spends at home in the first 90 days post-stroke (home days/DAH90 confirmed by patient follow-up and clinical note review.
Timepoint [2] 373498 0
90 days Post Thrombectomy
Secondary outcome [3] 373499 0
All cause mortality confirmed by patient follow-up and clinical note review.
Timepoint [3] 373499 0
90 days Post Thrombectomy
Secondary outcome [4] 373500 0
Proportion of patients with intra-procedural complications (target vessel dissection, intracerebral haemorrhage, groin haematoma) as documented in medical records.
Timepoint [4] 373500 0
From randomisation until 36 hours post treatment
Secondary outcome [5] 373503 0
Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment) as documented in medical records.
Timepoint [5] 373503 0
From randomisation until 36 hours post treatment

Eligibility
Key inclusion criteria
Adults equal to and greater than 18 years of age who fulfill all of the following inclusion criteria, none of the exclusion criteria, and have undergone an appropriate consenting process.

Inclusion criteria
Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2 segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patients presenting within 6-24 hours and favourable penumbra on perfusion scanning (see criteria 1-3).
Additional criteria in the 6 to 24-hour window.
1. ‘wake up’ stroke; CT with no (or at most minimal) acute infarction or
2. patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
3. patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI or CT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CT perfusion-CBF).
Minimum age
18 Years
Maximum age
No limit
Gender
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
• pre-stroke mRS>=3
• not having GA
• terminal illness with expected survival <1 year
• pregnancy
• cardiovascular conditions where BP targeting will be contra-indicated
• unable to participate in 3-month follow up

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)
A permuted block randomisation by centre generated 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
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Analyses will be performed in the intention-to- treat population. The measure of effect size of the primary outcome, mRS, will be a cumulative odds ratio as calculated by logistic regression (shift analysis). The primary analysis will be adjusted for factors including age, stroke severity (NIHSS) at baseline, occlusion of the internal carotid artery terminus, history of previous stroke, atrial fibrillation, diabetes mellitus and intravenous use of alteplase. Functional independence (mRS 0-2), 90-day mortality, procedural complications and sICH will be compared using relative risks with 95% CI. Home days (DAH90) will be analysed using quantile regression. Adjusted sensitivity analyses will be performed with robust Poisson regression for binary secondary outcomes and quantile regression for home days.

Baseline covariates will include age, gender, ethnicity, country of recruitment, baseline NIHSS, stroke territory, partial or complete vessel obstruction, use of alteplase, maintenance GA agent used.

All analyses will be conducted on an intention-to treat basis with no imputation of missing data.

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 outside Australia
Country [1] 21743 0
New Zealand
State/province [1] 21743 0
Auckland
Country [2] 21744 0
New Zealand
State/province [2] 21744 0
Christchurch
Country [3] 21745 0
New Zealand
State/province [3] 21745 0
Wellington
Country [4] 21746 0
Netherlands
State/province [4] 21746 0
Gottingen

Funding & Sponsors
Funding source category [1] 303473 0
Charities/Societies/Foundations
Name [1] 303473 0
Auckland District Health Board Charitable Trust
Address [1] 303473 0
Auckland District Health Board Research Office
Level 14, Support Building
Auckland City Hospital
Park Rd
Grafton
Auckland 1023
Country [1] 303473 0
New Zealand
Funding source category [2] 303479 0
Charities/Societies/Foundations
Name [2] 303479 0
Neurological Foundation
Address [2] 303479 0
66 Grafton Road
Grafton
Auckland
Auckland 1148
Country [2] 303479 0
New Zealand
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] 303531 0
None
Name [1] 303531 0
Address [1] 303531 0
Country [1] 303531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304003 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 304003 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304003 0
New Zealand
Date submitted for ethics approval [1] 304003 0
19/09/2019
Approval date [1] 304003 0
15/11/2019
Ethics approval number [1] 304003 0

Summary
Brief summary
Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95522 0
Dr Douglas Campbell
Address 95522 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 95522 0
New Zealand
Phone 95522 0
+64 93757095
Fax 95522 0
+6493754378
Email 95522 0
DCampbell@adhb.govt.nz
Contact person for public queries
Name 95523 0
Ms Davina McAllister
Address 95523 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 95523 0
New Zealand
Phone 95523 0
+64 93757095
Fax 95523 0
+6493754378
Email 95523 0
davinams@adhb.govt.nz
Contact person for scientific queries
Name 95524 0
Dr Douglas Campbell
Address 95524 0
Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 95524 0
New Zealand
Phone 95524 0
+64 93757095
Fax 95524 0
+6493754378
Email 95524 0
DCampbell@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this time the steering committee have not developed an IPD data sharing plan. Once the decision has been made regarding this process the information will be updated accordingly.
What supporting documents are/will be available?
No other documents available
Summary results
No Results