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
Scientific title
Paramedic Validation of the Ambulance Clinical Triage For Acute Stroke Treatment (ACT-FAST) Algorithm for Pre-hospital Clinical Endovascular-eligible Stroke Identification
Secondary ID [1] 293605 0
None
Universal Trial Number (UTN)
U1111-1206-6118
Trial acronym
ACT-FAST (Ambulance Clinical Triage For Acute Stroke Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 305863 0
Condition category
Condition code
Stroke 305067 305067 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299861 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 304237 0
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.
Timepoint [1] 304237 0
The theoretical time saving will be assessed following routine transport of the patient to the closest stroke hospital and administration of reperfusion therapy.
Secondary outcome [1] 341333 0
Accuracy of ACT-FAST Algorithm in comparison to patients with proven large vessel occlusion on Computed Tomographic Angiography.
Timepoint [1] 341333 0
This will be assessed following routine transport and treatment of the patient.
Secondary outcome [2] 341587 0
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.
Timepoint [2] 341587 0
This will be assessed following routine transport and treatment of the patient.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/11/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
200
Accrual to date
198
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298221 0
Hospital
Name [1] 298221 0
Melbourne Health
Country [1] 298221 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 297328 0
None
Name [1] 297328 0
Address [1] 297328 0
Country [1] 297328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299228 0
Melbourne Health HREC
Ethics committee address [1] 299228 0
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
Ethics committee country [1] 299228 0
Australia
Date submitted for ethics approval [1] 299228 0
Approval date [1] 299228 0
30/10/2017
Ethics approval number [1] 299228 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79730 0
Dr Henry Zhao
Address 79730 0
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
Country 79730 0
Australia
Phone 79730 0
+61 3 9342 7000
Fax 79730 0
+61 3 9342 8443
Email 79730 0
henry.zhao@mh.org.au
Contact person for public queries
Name 79731 0
Dr Henry Zhao
Address 79731 0
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
Country 79731 0
Australia
Phone 79731 0
+61 3 9342 7000
Fax 79731 0
+61 3 9342 8443
Email 79731 0
henry.zhao@mh.org.au
Contact person for scientific queries
Name 79732 0
Dr Henry Zhao
Address 79732 0
Royal Melbourne Hospital, Grattan St, Parkville VIC 3050
Country 79732 0
Australia
Phone 79732 0
+61 3 9342 7000
Fax 79732 0
+61 3 9342 8443
Email 79732 0
henry.zhao@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable data will be available on reasonable request
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.
Available to whom?
Unrestricted
Available for what types of analyses?
Unrestricted
How or where can data be obtained?
Direct request to principal investigator


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.