INTERACT4 Expansion - Validation Study

NCT07231315 | Not Yet Recruiting

• 1 other identifier: P01720
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Proportion of participants with ICH on hospital-based brain CT who are correctly identified as positive based on GFAP point-of-care measurement.

  From enrolment to initial CT scan up until 7 day assessment

• Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT.

  From enrolment to initial CT scan up until 7 day assessment

• Proportion of participants with a negative GFAP point-of-care measurement who are confirmed to not have an ICH on hospital-based brain CT.

  From enrolment to initial CT scan up until 7 day assessment

• Feasibility of recruitment, assessed by the proportion of enrolled participants over the number of stroke calls in the participating networks during the study period.

  From enrollment to end of the study.

• Feasibility of protocol delivery, assessed by the proportion of participants for whom all required study assessments in the ambulance were completed among those in whom assessments were initiated.

  From enrolment to transfer to hospital at day 1

Other Outcomes (1)

• Sensitivity, specificity, positive predictive value, and negative predictive value for identifying ICH using a (+) GFAP combined with a (-) D-dimer result on the point-of-care device, compared with hospital-based brain CT.

  From enrolment to initial CT scan up until 7 day assessment

Interventions

LVOne DIAGNOSTIC_TEST

LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected acute stroke presenting to ambulance services

You may qualify if:

• Adults (age ≥18 years);
• Acute syndrome that is due to presumed acute stroke, defined as FAST (Face, Arm, Speech, Time) scores of ≥2 with an arm motor deficit;
• Time ≤3 hours from last seen well;
• Systolic BP (SBP) ≥150mmHg.

You may not qualify if:

• 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;
• Severe known co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability \[needing help\]);
• Known history of epilepsy or seizure at onset;
• Recent head injury (where there is potential for another type of intracranial haemorrhage or head trauma);
• Hypoglycaemia (glucose\<4.0 mmol/L) as measured in the ambulance.

Sponsors & Collaborators

• The George Institute: lead

Study Sites (4)

Liverpool Hospital

Sydney, New South Wales, Australia

Location

Nepean Hospital

Sydney, New South Wales, Australia

Location

New South Wales Ambulance

Sydney, New South Wales, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Craig Anderson, MD

CONTACT

+61 4039448107; canderson@georgeinstitute.org.au

Cheryl Carcel, MD

CONTACT

ccarcel@georgeinsitute.org.au

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

AU (4)