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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | |
| ACTRN12619001274167 | Registry Identifier | Australia New Zealand Clinical Trials Registry |
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| Name | Class |
|---|---|
| The Australian and New Zealand College of Anaesthetists (ANZCA) | UNKNOWN |
| Neurological Foundation of New Zealand | UNKNOWN |
| The University of Queensland | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Additional criteria in the 6 to 24-hour window.
Exclusion Criteria:
Rescue"' procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass
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| Name | Affiliation | Role |
|---|---|---|
| Doug Campbell, Dr | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia | ||
| Gold Coast University Hospital |
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| Label | URL |
|---|---|
| Australia New Zealand College of Anaesthesia current research | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2024 | Dec 30, 2025 |
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| Auckland Medical Research Foundation |
| OTHER |
| Auckland Hospitals Research and Endowment Fund | UNKNOWN |
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Participant, investigators and outcome assessors are blinded to randomization allocation using opaque envelopes.
|
| 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 |
| Southport |
| Queensland |
| 4215 |
| Australia |
| Metro South Hospital and Health Service via the Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Auckland City Hopsital | Auckland | Auckland | 1023 | New Zealand |
| Christchurch Hospital | Christchurch | Canterbury | 8140 | New Zealand |
| Wellington Regional Hospital | Newton | Wellington Region | 6021 | New Zealand |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2025 | Dec 30, 2025 | SAP_002.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020766 | Intracranial Embolism |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002542 | Intracranial Embolism and Thrombosis |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
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