INTERACT4 Expansion: Seeing if a quick GFAP test can help ID brain bleeds before hospital care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an investigator-initiated, multi-centre, open-label, single-arm prospective observational study evaluating the feasibility of setting up a trial that uses a GFAP point-of-care test to identify intracerebral hemorrhage in patients with acute stroke-like symptoms before arrival at the hospital. Eligible participants are adults with suspected stroke within 3 hours of last known well, with high blood pressure and specific motor/face-speech deficits, excluding those with coma, severe comorbidities, epilepsy history, recent head injury, or hypoglycemia. The study is conducted at three sites in New South Wales, led by The George Institute, and uses LVOne as the intervention framework. Primary aim is feasibility of trial conduct and pre-hospital testing workflows. Outcomes will inform larger studies on pre-hospital triage and treatment pathways for stroke patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nepean Hospital
  Sydney, New South Wales, Australia Recruiting
• New South Wales Ambulance
  Sydney, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  Sydney, New South Wales, Australia Recruiting
• St George Hospital
  Sydney, New South Wales, Australia Recruiting
• Wollongong Hospital
  Sydney, New South Wales, Australia Recruiting
• Liverpool Hospital
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Study coordinator: Craig Anderson, MD
• Email: canderson@georgeinstitute.org.au
• Phone: +61 4039448107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.