Evaluation of a new fingerprick blood test for the identification of serious stroke

Not Applicable

• Conditions: Suspected acute stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN12414986
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39122395/ (added 12/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Last Update Posted: 26 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 552

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary objectives/analyses will examine the accuracy of the fingerprick test using different analysis populations