NCT05645861

Brief 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 Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable stroke

Geographic Reach
2 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

January 5, 2026

Status Verified

November 1, 2025

Enrollment Period

6.2 years

First QC Date

November 30, 2022

Last Update Submit

December 30, 2025

Conditions

StrokeEmbolus CerebralBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days Post Thrombectomy

Secondary Outcomes (5)

  • Independent functionality

    90 days Post Thrombectomy

  • Days Alive out of Hospital (DAOH)

    90 days Post Thrombectomy

  • All cause mortality

    90 days Post Thrombectomy

  • Intraprocedural complications

    From randomisation until 36 hours post treatment

  • Complicaiton of importance - symptomatic intracranial haemorrhage

    From randomisation until 36 hours post treatment

Study Arms (2)

Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg

ACTIVE COMPARATOR

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.

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

Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHgStandard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2 segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patients presenting within 6-24 hours and favourable penumbra on perfusion scanning (see criteria 1-3).
  • Additional criteria in the 6 to 24-hour window.
  • 'wake up' stroke; CT with no (or at most minimal) acute infarction or
  • patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
  • patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI or CT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CT perfusion-CBF).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Metro South Hospital and Health Service via the Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Auckland City Hopsital

Auckland, Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, Canterbury, 8140, New Zealand

Location

Wellington Regional Hospital

Newton, Wellington Region, 6021, New Zealand

Location

Related Links

MeSH Terms

Conditions

StrokeIntracranial Embolism

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Embolism and ThrombosisThromboembolismEmbolism and Thrombosis

Study Officials

  • Doug Campbell, Dr

    Auckland City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant, investigators and outcome assessors are blinded to randomization allocation using opaque envelopes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 12, 2022

Study Start

November 28, 2019

Primary Completion

January 31, 2026

Study Completion

February 28, 2026

Last Updated

January 5, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

At this time the steering committee have not developed an IPD data sharing plan. Once the decision has been made regarding this process the information will be updated accordingly.

Locations

AU(3)NZ(3)