Prehospital biomarker and phone call-based detection for ischaemic stroke thrombectomy
| ISRCTN | ISRCTN73432722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73432722 |
| IRAS number | 356128 |
| Secondary identifying numbers | CPMS68443 |
- Submission date
- 03/07/2025
- Registration date
- 11/07/2025
- Last edited
- 11/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
For some people who have a serious type of stroke called ‘large vessel occlusion stroke (LVO)’, an emergency operation called ‘thrombectomy’ is needed to remove a blood clot blocking an artery in the brain. The faster the thrombectomy is received, the better the chances of recovery. However, thrombectomy is very specialised and only available in certain regional hospitals.
Currently there are no specific assessments or tests that ambulance staff can use to work if LVO stroke is happening or if an urgent operation may be needed. Consequently, most patients with LVO stroke suitable for thrombectomy must be transferred to a specialised regional hospital after tests (e.g brain scans) at their local hospital. This takes extra time to get to thrombectomy.
This research is evaluating whether a new ambulance assessment is sufficiently accurate for future use. The assessment is for identifying people who have LVO stroke and may need thrombectomy. It consists of a fingerprick blood test (called ‘LVOne test’) and telephone communication between ambulance and hospital staff. The fingerprick test measures two blood chemicals called ‘d-dimer’and ‘GFAP’ and earlier research conducted in hospitals suggests that together these chemicals indicate LVO stroke. Other previous research has demonstrated that ambulance to hospital communicated clinical information has value for recognising people who need thrombectomy.
Who can participate?
Adults (aged 18 years and over) considered to be suffering from an acute stroke when assessed by ambulance staff.
What does the study involve?
Participants will undergo the new ambulance assessment which consists of a portable fingerprick blood test and telephone communication between ambulance and hospital staff. Following arrival at hospital, data will be collected about health symptoms, tests conducted, and treatments provided. Data will be analysed to determine how well the new ambulance assessment works to identify people with LVO stroke who may need thrombectomy.
What are the possible benefits and risks of participating?
This research is being conducted to determine whether a new ambulance assessment is sufficiently accurate for future use. 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 the research.
Where is the study run from?
North East Ambulance Service (UK)
Northumbria Specialist Emergency Care Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2025 to June 2026
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
Public, Scientific
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-3435-9519 |
|---|---|
| Phone | +44 1912086779 |
| lisa.shaw@newcastle.ac.uk |
Principal Investigator
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 1912086779 |
|---|---|
| c.i.m.price@newcastle.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Paramedicine |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | PRehospital biomarker and phoNe call-based detection for ischaemic stroke thrombecTOmy |
| Study acronym | PRONTO |
| Study objectives | The primary objective is to determine the diagnostic accuracy of the LVOne test for identification of large vessel occlusion stroke, when the test is used in the pre-hospital setting. A secondary objective is to determine the diagnostic accuracy of the LVOne test combined with specific clinical information communicated from ambulance practitioners to stroke teams for identification of patients suitable for direct admission to a thrombectomy centre. |
| Ethics approval(s) |
Submitted 16/05/2025, North East Newcastle and North Tyneside 1 (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 2071048384; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 25/NE/0109 |
| Health condition(s) or problem(s) studied | Suspected stroke |
| Intervention | This prospective observational cohort study is evaluating a lateral flow fingerprick blood test (called ‘LVOne test’) in combination with telephone communication of clinical information between ambulance and hospital staff. The lateral flow 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 fingerprick blood test result and reference standard tests |
| Secondary outcome measures | Secondary objectives/analyses will examine the accuracy of the fingerprick test combined with specific clinical information communicated from ambulance practitioners to stroke teams for identification of patients suitable for direct admission to a thrombectomy centre |
| Overall study start date | 01/03/2025 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 496 |
| Key inclusion criteria | Study trained ambulance practitioners will be asked to undertake the LVOne test and communicate clinical information to hospital on patients that fulfil the following criteria: 1. Being attended in the community after a 999 call 2. Being attended in a geographical region where ambulance conveyance is to a hospital participating in the study 3. Aged 18 years or over 4. Alert, Responds to Voice or Responds to Pain on the AVPU scale 5. New acute stroke suspected 6. FAST clinical symptom score of ≥ 1 7. Stroke symptoms begun within the last 6 hours (i.e. onset time is known and within the last 6 hours or the patient is known to have been symptom free within the last 6 hours) 8. Not been an inpatient in hospital or had an emergency hospital attendance within the last 7 days |
| Key exclusion criteria | Been an inpatient in hospital or had an emergency hospital attendance within the last 7 days |
| Date of first enrolment | 21/07/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Rake Lane
North Shields
NE29 8NH
United Kingdom
Goldcrest Way
Newburn Riverside
Newcastle Upon Tyne
NE15 8NY
United Kingdom
Sponsor information
Hospital/treatment centre
North Tyneside General Hospital
Rake Lane
North Shields
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 | 31/12/2026 |
|---|---|
| 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 |
Editorial Notes
03/07/2025: Trial's existence confirmed by North East Newcastle and North Tyneside 1.
