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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
550
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.
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
Auckland City Hopsital
Auckland, Auckland, New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Wellington Regional Hospital
Newton, Wellington Region, New Zealand
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.
Time frame: 90 days Post Thrombectomy
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.
Time frame: 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.
Time frame: 90 days Post Thrombectomy
All cause mortality
All cause mortality confirmed by patient follow-up and clinical note review.
Time frame: 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.
Time frame: 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.
Time frame: From randomisation until 36 hours post treatment
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