Evaluation of a new fingerprick blood test for the identification of serious stroke
| ISRCTN | ISRCTN12414986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12414986 |
| IRAS number | 323968 |
| Secondary identifying numbers | CPMS 55630, IRAS 323968 |
- Submission date
- 17/04/2023
- Registration date
- 02/05/2023
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Large vessel occlusion (LVO) stroke is a serious type of stroke caused by a blood clot blocking a large artery in the brain. For some people with LVO, an emergency operation (thrombectomy) to remove the blood clot improves the chances of recovery. However, the emergency operation is only available in specialist regional hospitals and most people must be transferred from their local hospital after a brain scan has been done to confirm the diagnosis. This results in delays to the emergency operation which can decrease the chance of recovery. Recently, a new portable fingerprick blood test has been developed which may be able to diagnose a likely LVO stroke. This study is assessing how well this new test works. If this new test works well, it could be done in ambulances in the future and people could then be taken directly to a regional hospital, saving time and reducing delays before treatment.
Who can participate?
Adults (aged 18 years and over) following emergency arrival at hospital who were assessed by ambulance personnel to be suffering from an acute stroke.
What does the study involve?
On arrival at hospital, participants will have the new fingerprick test, and data will be collected about the results of routine tests which are conducted to investigate a possible stroke. The new test result will be compared with routine tests to determine how well it works to diagnose likely LVO stroke.
What are the possible benefits and risks of participating?
This research is being conducted to determine if the new fingerprick test may be useful for identifying LVO stroke. There are no direct benefits to individuals who take part in the study, however, it is hoped that care for future patients will be improved as a result of this research.
Where is the study run from?
1. Royal Victoria Infirmary (UK)
2. Northumbria Specialist Emergency Care Hospital (UK)
3. University Hospital of North Durham (UK)
4. Royal Blackburn Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2022 to June 2025
Who is funding the study?
Small Business Research Initiative for Healthcare (UK)
Who is the main contact?
Dr Lisa Shaw, lisa.shaw@newcastle.ac.uk
Contact information
Scientific
First floor
Henry Wellcome Building
Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 208 3826 |
|---|---|
| lisa.shaw@newcastle.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Rapid Assay Diagnostic for Acute stroke Recognition (RADAR) |
| Study acronym | RADAR |
| Study objectives | The primary objective is to determine the diagnostic accuracy of a new portable fingerprick blood test for the identification of large vessel occlusion (LVO) stroke. |
| Ethics approval(s) | Approved 21/03/2023, North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHS BT Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ, UK; +44 (0)2071048091; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 23/NE/0043 |
| Health condition(s) or problem(s) studied | Suspected acute stroke |
| Intervention | This research project is a prospective observational cohort study to evaluate the diagnostic accuracy of a new fingerprick blood test for the identification of LVO stroke. The fingerprick test measures blood levels of d-dimer and glial fibrillary acidic protein (GFAP). |
| Intervention type | Other |
| Primary outcome measure | Sensitivity, specificity, positive and negative predictive values for identification of LVO stroke calculated from the new fingerprick blood test result and reference standard tests. |
| Secondary outcome measures | Secondary objectives/analyses will examine the accuracy of the fingerprick test using different analysis populations |
| Overall study start date | 01/12/2022 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 552; UK Sample Size: 552 |
| Total final enrolment | 608 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Arrived at the study hospital by emergency ambulance 3. New acute stroke suspected by ambulance personnel before hospital arrival 4. FAST clinical symptom score is ≥1 (as determined by hospital staff) 5. Stroke symptoms are known to have begun within the last 6 hours OR the patient was last known to be well between 6 and 24 hours ago (times determined by hospital specialist staff) 6. Blood sampling can be undertaken prior to any reperfusion treatments 7. Routine brain imaging is intended to be urgently performed |
| Key exclusion criteria | 1. Already assessed at another hospital and ambulance admission is a transfer for continuing care 2. Assigned a recent previous (within the last 4 weeks) diagnosis of deep vein thrombosis, pulmonary embolism, arterial embolism, stroke, TIA, long bone fracture, major trauma, any surgery under general anaesthesia (these diagnoses may have resulted in elevated d-dimer) 3. Suffered a recent previous (within the last 4 weeks) head injury which lead to hospital attendance (this event may have resulted in elevated GFAP) 4. Stroke symptoms are known to have begun greater than 6 hours ago |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newcastle upon Tyne
TS1 4LP
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Durham
DH1 5TW
United Kingdom
Blackburn
BB2 3HH
United Kingdom
London
SW17 0QT
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Sponsor information
Hospital/treatment centre
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
| Phone | +44 (0)1912934087 |
|---|---|
| peta.heslop@northumbria-healthcare.nhs.uk | |
| Website | https://www.northumbria.nhs.uk/ |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 09/08/2024 | 12/08/2024 | Yes | No |
Editorial Notes
16/06/2025: Contact details updated.
24/03/2025: The total final enrolment was added.
20/09/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2024 to 31/03/2025.
2. The overall end date was changed from 31/12/2024 to 30/06/2025.
3. The intention to publish date was changed from 31/12/2024 to 30/06/2025.
4. The plain English summary was updated to reflect these changes.
5. The study participating centres St George's Hospital, New Cross Hospital were added.
12/08/2024: Publication reference added.
15/03/2024: The recruitment end date was changed from 31/03/2024 to 30/09/2024.
17/04/2023: Trial's existence confirmed by the NIHR.
