Rapid Ambulance Diagnosis Of Stroke (RADIOS)
Research type
Research Study
Full title
Rapid Ambulance Diagnosis Of Stroke (RADIOS): a pre-hospital feasibility study
IRAS ID
332951
Contact name
Elizabeth Warburton
Contact email
Sponsor organisation
Pockit diagnostics Ltd
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
This is a prospective feasibility study involving collection and analysis of a small amount of blood sample which aims to establish the usability of the LVOne test in a routine testing in an emergency care environment for patients with suspected stroke.
Eligible 30 patients with suspected stroke will be assessed during pre-hospital part of a care by an ambulance team, meeting score ≥ 2 on the Face Arm Speech Test (FAST) clinical symptom scale and are known to be within 6 hours of symptom onset.
LVOne test consists of two portable lateral flow assays: assay 1 measures blood d-dimer concentration and assay 2 measures blood glial fibrillary acidic protein (GFAP) concentration.
Expert clinician opinion will establish the following clinical outcomes: ischaemic stroke +/- large vessel occlusion; intracerebral haemorrhage; transient ischaemic attack; non-stroke mimic condition.
Currently, no tools are used in the pre-hospital settings to identify LVO and redirect suspected patients to regional Mechanical Thrombectomy (MT) providers. Therefore, tools to help ambulance clinicians diagnose LVO and transport patients immediately to a thrombectomy centre are vital.
The main study analysis will be the ambulance team’s opinions on the usability of the LVOne test during routine ambulance visits for the pre-hospital evaluation of LVO stroke.
Additional studies will establish the accuracy of the test so the test accuracy is not a primary objective of this study but hope easy ambulance team finds it when used in ambulance environment.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0226
Date of REC Opinion
25 Oct 2023
REC opinion
Unfavourable Opinion