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.
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.
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.
- '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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study 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
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal North Shore Hospital
Select from list below to view details:
Royal North Shore Hospital
Sydney, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Metro South Hospital and Health Service via the Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
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Who is running the clinical trial?
Auckland City Hospital
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
| Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg |
ACTIVE_COMPARATOR: Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg
| Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg |
What is the study measuring?
Primary Outcome
| 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
| 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 |
| 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 |
References
Clinical Trials Gov: MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKEOther trials to consider
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