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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12618000147280
Ethics application status
Approved
Date submitted
13/12/2017
Date registered
31/01/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
13/03/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Ambulance Clinical Triage For Acute Stroke Treatment (ACT-FAST) Clinical Algorithm Validation Study for Identification of Endovascular-eligible Stroke
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Scientific title
Paramedic Validation of the Ambulance Clinical Triage For Acute Stroke Treatment (ACT-FAST) Algorithm for Pre-hospital Clinical Endovascular-eligible Stroke Identification
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Secondary ID [1]
293605
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None
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Universal Trial Number (UTN)
U1111-1206-6118
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Trial acronym
ACT-FAST (Ambulance Clinical Triage For Acute Stroke Treatment)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
305863
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Condition category
Condition code
Stroke
305067
305067
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The 3-step ACT-FAST Algorithm (Step 1 - Arm weakness, Step 2 - Severe speech deficit [right arm weak] or severe gaze deviation/hemi-neglect [left arm weak], Step 3 - Endovascular eligibility and stroke mimic screen) will be assessed by Ambulance Victoria paramedics in all suspected stroke/TIA patients in the state of Victoria. Patients will be designated as ACT-FAST Positive (all steps fulfilled) or ACT-FAST Negative (any step not fulfilled) on Victorian Ambulance Clinical Information System.
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Intervention code [1]
299861
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Early detection / Screening
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Comparator / control treatment
The theoretical time saving from bypass of ACT-FAST Positive patients to the nearest endovascular centre will be calculated retrospectively from geospatial tracking software and compared to real-world scene-to-endovascular-treatment times using standard Ambulance Victoria transport protocols to the closest stroke hospital. Control data will be collected over the same time period as study data.
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Control group
Active
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Outcomes
Primary outcome [1]
304237
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Theoretical mean time difference in using ACT-FAST Algorithm to triage stroke patients directly to an endovascular centre, compared with standard transport protocols to the closest stroke hospital. This will be calculated retrospectively using geospatial tracking software.
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Assessment method [1]
304237
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Timepoint [1]
304237
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The theoretical time saving will be assessed following routine transport of the patient to the closest stroke hospital and administration of reperfusion therapy.
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Secondary outcome [1]
341333
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Accuracy of ACT-FAST Algorithm in comparison to patients with proven large vessel occlusion on Computed Tomographic Angiography.
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Assessment method [1]
341333
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Timepoint [1]
341333
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This will be assessed following routine transport and treatment of the patient.
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Secondary outcome [2]
341587
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Theoretical mean time difference from symptom-onset-to-thrombolysis for ACT-FAST Positive patients who are thrombolysis-eligible but do not require endovascular thrombectomy had theoretical bypass occurred. This will be calculated by comparing theoretical bypass transport times by geospatial tracking software in comparison to real inter-hospital transfer times.
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Assessment method [2]
341587
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Timepoint [2]
341587
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This will be assessed following routine transport and treatment of the patient.
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Eligibility
Key inclusion criteria
All suspected stroke/TIA patients that are attended to by Ambulance Victoria paramedics in the state of Victoria. Recruitment must occur prior to hospital arrival.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Nil
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The primary outcome measure of mean time difference between theoretical bypass versus
control will be assessed using the 2-tailed student’s t-test with a significant difference
regarded as p-value <0.05.
For secondary outcomes, sensitivity analysis of ACT-FAST Algorithm in comparison to
vessel imaging will be carried out to determine overall accuracy. Difference in mean tPA
treatment times will also be calculated using the 2-tailed student’s t-test.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
20/11/2017
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Date of last participant enrolment
Anticipated
31/12/2019
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Actual
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Date of last data collection
Anticipated
31/12/2019
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Actual
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Sample size
Target
200
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Accrual to date
198
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
298221
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Hospital
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Name [1]
298221
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Melbourne Health
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Address [1]
298221
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Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Country [1]
298221
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Australia
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Primary sponsor type
Hospital
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Name
Melbourne Health
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Address
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Country
Australia
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Secondary sponsor category [1]
297328
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None
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Name [1]
297328
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Address [1]
297328
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Country [1]
297328
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299228
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Melbourne Health HREC
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Ethics committee address [1]
299228
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Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Ethics committee country [1]
299228
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Australia
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Date submitted for ethics approval [1]
299228
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Approval date [1]
299228
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30/10/2017
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Ethics approval number [1]
299228
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Summary
Brief summary
This study aims to validate the 3-step ACT-FAST Algorithm, designed to allow paramedics to recognise stroke patients that require endovascular clot retrieval surgery. Paramedics will assess the algorithm for all suspected stroke and TIA patients prior to arrival in hospital. The study will examine whether the algorithm is accurate in determining need for endovascular clot retrieval, and how much time would have been saved had the patient been taken directly to a hospital capable of endovascular treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
79730
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Dr Henry Zhao
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Address
79730
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Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Country
79730
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Australia
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Phone
79730
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+61 3 9342 7000
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Fax
79730
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+61 3 9342 8443
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Email
79730
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[email protected]
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Contact person for public queries
Name
79731
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Dr Henry Zhao
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Address
79731
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Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Country
79731
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Australia
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Phone
79731
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+61 3 9342 7000
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Fax
79731
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+61 3 9342 8443
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Email
79731
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[email protected]
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Contact person for scientific queries
Name
79732
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Dr Henry Zhao
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Address
79732
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Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
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Country
79732
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Australia
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Phone
79732
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+61 3 9342 7000
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Fax
79732
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+61 3 9342 8443
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Email
79732
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Non-identifiable data will be available on reasonable request
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When will data be available (start and end dates)?
Project data is expected to be available 01/01/2020 onwards. IPD data will available for at least 5 years (01/01/2025) following.
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Available to whom?
Unrestricted
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Available for what types of analyses?
Unrestricted
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How or where can data be obtained?
Direct request to principal investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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