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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke Embolus Cerebral Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant, investigators and outcome assessors are blinded to randomization allocation using opaque envelopes.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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 Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doug Campbell, Dr

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

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Royal North Shore Hospital

Sydney, New South Wales, Australia

Site Status

Gold Coast University Hospital

Southport, Queensland, Australia

Site Status

Metro South Hospital and Health Service via the Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Auckland City Hopsital

Auckland, Auckland, New Zealand

Site Status

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Site Status

Wellington Regional Hospital

Newton, Wellington Region, New Zealand

Site Status

Countries

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Australia New Zealand

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document