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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05645861




Registration number
NCT05645861
Ethics application status
Date submitted
30/11/2022
Date registered
12/12/2022
Date last updated
24/09/2024

Titles & IDs
Public title
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE
Scientific title
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial
Secondary ID [1] 0 0
ACTRN12619001274167
Secondary ID [2] 0 0
MasterStroke vs 1.3
Universal Trial Number (UTN)
Trial acronym
MASTERSTROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Embolus Cerebral 0 0
Blood Pressure 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg

Active comparator: Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg - 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.

Active comparator: Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg - 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.


Treatment: Surgery: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Day 90 Modified Rankin Score
Timepoint [1] 0 0
90 days Post Thrombectomy
Secondary outcome [1] 0 0
Independent functionality
Timepoint [1] 0 0
90 days Post Thrombectomy
Secondary outcome [2] 0 0
Days Alive out of Hospital (DAOH)
Timepoint [2] 0 0
90 days Post Thrombectomy
Secondary outcome [3] 0 0
All cause mortality
Timepoint [3] 0 0
90 days Post Thrombectomy
Secondary outcome [4] 0 0
Intraprocedural complications
Timepoint [4] 0 0
From randomisation until 36 hours post treatment
Secondary outcome [5] 0 0
Complicaiton of importance - symptomatic intracranial haemorrhage
Timepoint [5] 0 0
From randomisation until 36 hours post treatment

Eligibility
Key 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
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

* 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Metro South Hospital and Health Service via the Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Government body
Name
Auckland City Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Stroke is the third most common cause of death in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. In New Zealand, 90% of clot retrieval procedures are performed under general anaesthesia. Many anaesthetic drugs can affect blood pressure (BP) and blood flow within the brain. Increasing BP during the procedure could provide additional benefits in this devastating disease. A large trial is needed to investigate BP management during clot retrieval.
Trial website
https://clinicaltrials.gov/study/NCT05645861
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Doug Campbell, Dr
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Davina J McAllister, DipNursing
Address 0 0
Country 0 0
Phone 0 0
+6493757095
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05645861