Differentiation of intracerebral hemorrhage (ICH) and large vessel occlusion (LVO) from other suspected stroke cases in adult patients presenting with stroke-like symptoms. Circulatory System
Conditions
Interventions
This is an observational study with no interventions. The study methodology involves:
1. Collecting clinical features from suspected stroke patients upon hospital arrival, as documented in ambulance a
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. The patient arrived at the study hospital via emergency ambulance. 2. The patient is 18 years of age or older. 3. Ambulance staff suspected a new acute stroke prior to arrival at the hospital. 4. Stroke symptoms began within 6 hours of sample collection (if the onset was not witnessed, the patient was last known to be well less than 6 hours ago). 5. Blood samples can be collected prior to the administration of any treatment. 6. Urgent brain imaging is planned as part of the patient's diagnostic pathway.
Exclusion criteria
Exclusion criteria: 1. The patient was assessed at another hospital and transferred for ongoing care. 2. The patient had a recent diagnosis (within the last 4 weeks) of deep vein thrombosis, pulmonary embolism, arterial embolism, stroke, transient ischaemic attack, long bone fracture, major trauma, or surgery under general anaesthesia, as these conditions may increase D-dimer levels. 3. The patient had a recent head injury (within the last 4 weeks) requiring hospital care, as this may increase GFAP levels. 4. Stroke symptoms started more than 6 hours prior to sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy of models for determining intracerebral haemorrhage (ICH) is measured using point-of-care GFAP and D-dimer tests (LVOne test) at baseline and prior to hospital discharge 2. Diagnostic accuracy of models for determining large vessel occlusion (LVO) is measured using point-of-care GFAP and D-dimer tests (LVOne test) at baseline and prior to hospital discharge 3. Final diagnoses of intracerebral haemorrhage (ICH) are measured using CT/MRI prior to hospital discharge 4. Final diagnoses of large vessel occlusion (LVO) are measured using CT/MRI prior to hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, positive predictive value, and negative predictive value for identifying intracerebral haemorrhage (ICH) and large vessel occlusion (LVO) are measured using the LVOne test (GFAP and D-dimer levels) compared with final diagnoses determined by brain imaging (CT/MRI) at baseline (on hospital arrival) and prior to hospital discharge 2. Diagnostic accuracy metrics of the developed models compared with those of the Face Arm Speech Test (FAST) and other standard diagnostic tools are measured using a retrospective review of ambulance and hospital patient records at baseline (on hospital arrival) to study completion 3. Evidence of the impact of diagnostic models on clinical decision-making, such as changes in treatment pathways or triage decisions, is measured using a retrospective analysis of clinical pathways and decisions documented in patient notes from baseline (on hospital arrival) to study completion | — |
Countries
England, United Kingdom
Contacts
Public ContactAdrian Parry-Jones
Outcome results
None listed