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

Last updated: September 22, 2024
Sponsor: Auckland City Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Thrombosis

Treatment

Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg

Clinical Study ID

NCT05645861
MasterStroke vs 1.3
2119013
1920 PG
22/001
A+ 8173
ACTRN12619001274167
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patientspresenting within 6-24 hours and favourable penumbra on perfusion scanning (seecriteria 1-3).

Additional criteria in the 6 to 24-hour window.

  1. 'wake up' stroke; CT with no (or at most minimal) acute infarction or

  2. patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI orCT perfusion-CBF)

  3. patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI orCT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CTperfusion-CBF).

Exclusion

Exclusion Criteria:

  • Rescue"' procedures eg acute ischaemic stroke associated with major medicalprocedures 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

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
Phase:
Study Start date:
November 28, 2019
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Metro South Hospital and Health Service via the Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Christchurch Hospital

    Christchurch, Canterbury 8140
    New Zealand

    Active - Recruiting

  • Wellington Regional Hospital

    Newton, Wellington 6021
    New Zealand

    Active - Recruiting

  • Auckland City Hopsital

    Auckland, 1023
    New Zealand

    Active - Recruiting

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