RecruitingObservational

Improving stroke diagnosis: A study using blood tests and clinical information to quickly identify stroke types in suspected stroke patients

A stroke is a medical emergency that happens when blood supply to part of the brain is cut off by a clot, or when a blood vessel bursts and bleeds into the brain. Both types require very different and urgent treatments. However, standard ambulance tests cannot reliably tell them apart. This UK study is evaluating a new diagnostic tool that combines normal hospital checks with a quick finger-prick blood test, known as the LVOne test. Researchers want to see if this test can spot specific blood markers that identify whether a patient has a severe clot or bleeding in the brain. Adults brought to hospital by ambulance within six hours of stroke symptoms starting may be eligible. Taking part does not delay normal NHS care or test any new drugs. The goal is to help future stroke patients get the correct, life-saving care much more quickly.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

257

Start

01 Oct 2025

Estimated completion

27 Jan 2027

Differentiation of intracerebral hemorrhage (ICH) and large vessel occlusion (LVO) from other suspected stroke cases in adult patients presenting with stroke-like symptoms.

What is this study about?

A stroke occurs when blood cannot reach part of your brain or when bleeding happens inside the brain. Both situations are medical emergencies that require immediate care, but their treatments are very different. A blocked blood vessel is treated with medicines or procedures to dissolve or remove the clot. A bleed requires treatments to stop the bleeding and reduce pressure. Giving clot-busting medicine to someone with a brain bleed can be extremely dangerous, so doctors must be certain of the cause before acting.

Currently, hospital teams rely on emergency brain scans, such as CT scans, to find out which type of stroke has happened. While these scans are very effective, arranging and completing them takes valuable time. Simple screening tools used by paramedics can spot that a stroke is happening, but they cannot tell what kind of stroke it is.

This study, run by the University of Manchester, is testing a new approach called the LVOne test. It uses a quick finger-prick blood test alongside standard clinical checks. The test looks for natural markers in the blood that signal whether there is a major blockage or bleeding in the brain.

By comparing the blood test results with patients' final hospital scan results, the research team wants to prove whether this rapid test is accurate and reliable. If successful, the test could help NHS emergency teams make faster decisions in the future, getting patients to the right treatments without delay.

Key takeaways

Tests a rapid finger-prick blood test to quickly identify the type of stroke a person is having.
Aims to distinguish between bleeding in the brain and a major blood clot.
Open to adults arriving by ambulance within six hours of stroke symptoms starting.
Involves a single finger prick and does not delay any standard emergency NHS care.
Does not test any new medications or require extra hospital visits.

Who may be eligible?

This study is designed for adults aged 18 and older who are brought to a participating hospital emergency department by ambulance because of a suspected acute stroke. To take part, stroke symptoms must have started less than six hours before the blood sample is collected, or the person must have been known to be well within the past six hours. Brain imaging must also be planned as part of their routine care.

Because the test looks closely at specific proteins and clotting markers in the blood, recent physical injuries or other conditions can change the results. For this reason, patients cannot take part if they have had a head injury requiring hospital care in the last four weeks.

People are also unable to join if they have had surgery under general anaesthetic, a broken long bone, major trauma, another stroke, a mini-stroke (TIA), or a blood clot such as deep vein thrombosis (DVT) in the last four weeks. Patients transferred from another hospital are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Did you arrive at the hospital by emergency ambulance with suspected stroke symptoms?
Did your symptoms begin less than 6 hours ago (or were you last seen well within 6 hours)?
Have you been free from major trauma, bone fractures, and surgery in the last 4 weeks?
Have you been free from head injuries requiring hospital treatment in the last 4 weeks?

Answer every question to see your result.

What does participation involve?

Taking part in this study happens entirely while you are in the emergency department receiving treatment for suspected stroke symptoms. There are no extra hospital visits, no follow-up appointments, and no changes to your medical care.

A doctor, nurse, or researcher will take a small drop of blood using a quick finger prick, very similar to a standard blood sugar check. Where possible, they may also collect a small additional sample during your routine blood tests. The study team will then record details about your symptoms and look at the results of your routine brain scans and hospital records.

You will not receive any experimental drugs. The results of the research blood test are not used to direct your treatment; your medical team will care for you using standard NHS scans and guidelines. Once your medical data is recorded, your involvement in the study is complete.

Potential risks and benefits

There is no direct personal medical benefit from taking part in this study, as all your care decisions will be made using standard NHS hospital scans and tests. However, your participation could help develop faster, better diagnostic tools for future stroke patients. The physical risks are very low and are limited to brief stinging or minor bruising from the finger prick or blood draw. Taking part is completely voluntary. If you or your family decide not to join, or choose to withdraw later, your standard medical care will not be affected in any way.

Locations (3)

Northern Care Alliance NHS Foundation Trust
City only
Salford, England
Stockport NHS Foundation Trust
City only
Stockport, England
Fairfield General Hospital
Approximate
Bury, England

Common questions

Will taking part delay my emergency stroke treatment?

No. Your emergency care and scans always come first. The finger-prick sample is taken quickly alongside your normal care and will not hold up your treatment.

Will the blood test results change the treatment I receive?

No. The blood test is being tested for research purposes only. Your doctors will make all treatment decisions based on standard hospital brain scans.

Do I have to take any new medications?

No. This is an observational study, which means researchers are only observing and testing blood samples. No new medicines are given.

What happens if a patient cannot communicate to give consent?

Because a stroke can affect speech and consciousness, researchers follow strict legal and ethical guidelines. They may consult a family member or nominated representative to ensure the patient's rights and wishes are respected.

Are there any costs or payments involved?

No. Taking part is free, happens during standard NHS emergency care, and participants are not paid.

How to find out more

Adrian Parry-Jones

adrian.parry-jones@manchester.ac.uk (+44) 161 206 4458 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.