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Active Not RecruitingNCT05645861

MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE

MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
550 (estimated)
Sponsor
Auckland City Hospital · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBlood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHgTechniques 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.

Timeline

Start date
2019-11-28
Primary completion
2026-01-31
Completion
2026-02-28
First posted
2022-12-12
Last updated
2026-01-05

Locations

6 sites across 2 countries: Australia, New Zealand

Source: ClinicalTrials.gov record NCT05645861. Inclusion in this directory is not an endorsement.