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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.