MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE (MASTERSTROKE)

MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Blood Pressure; Embolus Cerebral
• Intervention / Treatment: Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Metro South Hospital and Health Service via the Princess Alexandra Hospital
• New Zealand
  • Auckland
    • Auckland, Auckland, New Zealand, 1023
      • Auckland City Hopsital
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8140
      • Christchurch Hospital
  • Wellington Region
    • Newton, Wellington Region, New Zealand, 6021
      • Wellington Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 90 Modified Rankin Score	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who are deceased.	90 days Post Thrombectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days Alive out of Hospital (DAOH)	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.	90 days Post Thrombectomy
All cause mortality	All cause mortality confirmed by patient follow-up and clinical note review.	90 days Post Thrombectomy
Complicaiton of importance - symptomatic intracranial haemorrhage	Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment) as documented in medical records.	From randomisation until 36 hours post treatment
Independent functionality	Independent functional outcome as determined by a modified Rankin Score of 0,1,or 2 at 90 Days. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who are deceased.	90 days Post Thrombectomy
Intraprocedural complications	Proportion of patients with intra-procedural complications (target vessel dissection, intracerebral haemorrhage, groin haematoma) as documented in medical records.	From randomisation until 36 hours post treatment

Collaborators and Investigators

• Sponsor: Auckland City Hospital
• Collaborators: The University of Queensland; Auckland Medical Research Foundation; The Australian and New Zealand College of Anaesthetists (ANZCA); Neurological Foundation of New Zealand; Auckland Hospitals Research and Endowment Fund
• Investigators: Principal Investigator: Doug Campbell, Dr, Auckland City Hospital

Publications and helpful links

Helpful Links

• Australia New Zealand College of Anaesthesia current research

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Stroke; Intracranial Embolism; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: MasterStroke vs 1.4; ACTRN12619001274167 (Registry Identifier: Australia New Zealand Clinical Trials Registry); 1920 PG (Other Grant/Funding Number: Neurological Foundation); 22/001 (Other Grant/Funding Number: Australia New Zealand College of Anaesthesia); A+ 8173 (Other Grant/Funding Number: Auckland Hospitals Research and Endowment Fund); 2119013 (Other Grant/Funding Number: Auckland Medical Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No