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

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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).

'wake up' stroke; CT with no (or at most minimal) acute infarction

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2019-11-28

Primary completion: 2024-12-31

Study completion finish: 2025-06-30

Study type

TREATMENT

Phase

Trial ID

NCT05645861

Intervention or treatment

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

Conditions

• Stroke
• Embolus Cerebral
• Blood Pressure

Condition: Stroke, Embolus Cerebral and more
PROCEDURE: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
Woolloongabba, Queensland, Australia
Sponsor: Auckland City Hospital

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Metro South Hospital and Health Service via the Princess Alexandra Hospital

Research sites nearby

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Metro South Hospital and Health Service via the Princess Alexandra Hospital
Woolloongabba, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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
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
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
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

Frequently Asked Questions

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References

Clinical Trials Gov: MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE