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Evaluation of blood biomarkers for the identification of serious stroke

Stroke Biomarker Evaluation for Large Vessel Occlusion (StroBE-LVO)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN60633358
Enrollment
130
Registered
2022-04-26
Start date
2022-07-15
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected acute stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

This research project is a prospective observational cohort study to determine whether blood concentrations of d-dimer and/or whole blood purine can predict the presence of large vessel occlusion stro

Sponsors

Northumbria Healthcare NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. At least responsive to tactile stimuli (i.e. A, V or P on the AVPU scale) on hospital arrival 5. New suspected stroke symptoms are still present when taking blood measurements 6. Blood sampling can be undertaken within 6 hours of suspected stroke symptom onset/last known well (times determined by hospital specialist staff) 7. Blood sampling can be undertaken prior to any reperfusion treatments 8. Routine brain imaging is intended to be urgently performed

Exclusion criteria

Exclusion criteria: 1. Already assessed at another hospital and ambulance admission is a transfer for continuing care 2. Hypoglycaemia (capillary glucose <3.5 mmol/l) 3. External signs of significant acute trauma which are likely to need additional treatment (large haematomas, open wounds, limb deformity) 4. Assigned a recent previous (within the last 4 weeks) diagnosis likely to have resulted in elevated D-dimer levels i.e. deep vein thrombosis, pulmonary embolism, arterial embolism, stroke, long bone fracture, major trauma, any surgery under general anaesthesia 5. Chemotherapy or radiotherapy treatment for cancer within the last 7 days

Design outcomes

Primary

MeasureTime frame
Area under the Receiving Operating Curve (ROC), sensitivity, specificity, negative and positive predictive values for identification of LVO stroke calculated from blood values and reference standard tests

Secondary

MeasureTime frame
Area under the Receiving Operating Curve (ROC), sensitivity, specificity, negative and positive predictive values for identification of any stroke calculated from blood values and reference standard tests

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026