MASTERSTROKE Trial
Design
This multicentre, pragmatic, double-blind, randomised clinical trial will compare functional recovery after general anaesthesia (GA) for endovascular thrombectomy (EVT) in acute ischaemic stroke.
Study intervention
A target systolic blood pressure of 140 mm Hg compared to 170 mmHg during GA for EVT from start of procedure until recanalization. All other aspects of anaesthesia and procedural care are flexible.
Primary endpoint
Modified Rankin Score (mRS) at 3 months
Secondary endpoints
Good functional recovery at 3 months (mRS 0-2), excellent functional recovery at 3 months (mRS 0-1), and the number home days within 90 days (DAH90).
Safety endpoints
Symptomatic intracranial haemorrhage, 3-month mortality, procedural complications, adverse events.
Entry criteria
Adult patients scheduled for EVT under GA
Sample size
550 patients
Study duration
4 years
Funding
Neurological Foundation of New Zealand, Auckland Medical Research Foundation, Auckland District Health Board Research Trust.
For further information
Please contact Davina McAllister davinams@adhb.govt.nz or +64 9 3757095
Lay Summary
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.
Trial Registration
The MASTERSTROKE trial is registered with the Australian New Zealand Clinical Trials Registry (Registration number ACTRN12619001274167p). More information can be accessed at the Australian New Zealand Clinical Trials Registry website
Ethical Approval
Ethical approval has been provided by the Health and Disability Ethics Committee (19/NTB/163, Northern B Health and Disability Ethics Committee)
Pilot Study
The MASTERSTROKE pilot trial provided data on the feasibility of a large trial. The MASTERSTROKE pilot trial was published in Anaesthesia in 2020 and can be accessed here.