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INTERACT4 Expansion - Validation Study

Recruitingn/aAges 18 Years - anyAllThe George Institute
NCT07231315 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the feasibility of setting up and conducting a trial that uses a point-of-care GFAP test to identify ICH in patients presenting with acute stroke-like symptoms in the pre-hospital setting.

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📋 Eligibility rules (as published)
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.
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What it tests

  • LVOne
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Where

6 sites
Liverpool Hospital
Sydney, Australia
Nepean Hospital
Sydney, Australia
New South Wales Ambulance
Sydney, Australia
Royal North Shore Hospital
Sydney, Australia
St George Hospital
Sydney, Australia
Wollongong Hospital
Sydney, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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