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NCT Number: NCT05645861

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

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.

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Key information

Conditions

Stroke Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Embolus Cerebral Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • 'wake up' stroke; CT with no (or at most minimal) acute infarction or
  • patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
  • 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

Treatment and study plan

Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg

Procedure

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.

Primary outcomes

  1. Day 90 Modified Rankin Score

    Time frame: 90 days Post Thrombectomy

    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.

Secondary outcomes

  1. Independent functionality

    Time frame: 90 days Post Thrombectomy

    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.

  2. Days Alive out of Hospital (DAOH)

    Time frame: 90 days Post Thrombectomy

    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.

  3. All cause mortality

    Time frame: 90 days Post Thrombectomy

    All cause mortality confirmed by patient follow-up and clinical note review.

  4. Intraprocedural complications

    Time frame: From randomisation until 36 hours post treatment

    Proportion of patients with intra-procedural complications (target vessel dissection, intracerebral haemorrhage, groin haematoma) as documented in medical records.

  5. Complicaiton of importance - symptomatic intracranial haemorrhage

    Time frame: From randomisation until 36 hours post treatment

    Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment) as documented in medical records.

Sponsors and collaborators

Lead sponsor

Auckland City Hospital

Other Gov

Collaborators

  • Auckland Hospitals Research and Endowment Fund
  • Auckland Medical Research Foundation
  • Neurological Foundation of New Zealand
  • The Australian and New Zealand College of Anaesthetists (ANZCA)
  • The University of Queensland

Registry information

Official study title

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

Acronym: MASTERSTROKE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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