LVOne: LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit
Study summary
As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the diagnostic accuracy of GFAP measured using a point-of-care device, for identifying ICH in participants presenting with acute stroke-like symptoms in the pre-hospital setting compared with imaging-confirmed ICH.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Adults (age ≥18 years);
2. Acute syndrome that is due to presumed acute stroke, defined as FAST (Face, Arm, Speech, Time) scores of ≥2 with an arm motor deficit;
3. Time ≤3 hours from last seen well;
4. Systolic BP (SBP) ≥150mmHg.
Exclusion Criteria:
1. Participants in coma (no response to tactile/verbal stimulation); or/and do not respond to "P" or "U" on the alert/verbal/painful/unresponsive (APVU) responsiveness scale;
2. Severe known co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability \[needing help\]);
3. Known history of epilepsy or seizure at onset;
4. Recent head injury (where there is potential for another type of intracranial haemorrhage or head trauma);
5. Hypoglycaemia (glucose\<4.0 mmol/L) as measured in the ambulance.
Primary outcome measure(s)
Proportion of participants without ICH on hospital-based brain CT who are correctly identified as negative based on GFAP point-of-care measurement. (Specificity) — From enrolment to initial CT scan up until 7 day assessment
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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