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NCT Number: NCT07231315

INTERACT4 Expansion - Validation Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

LVOne

Diagnostic Test

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

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)

    Time frame: From enrolment to initial CT scan up until 7 day assessment

Secondary outcomes

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

    Time frame: From enrolment to initial CT scan up until 7 day assessment

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

    Time frame: From enrolment to initial CT scan up until 7 day assessment

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

    Time frame: From enrolment to initial CT scan up until 7 day assessment

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

    Time frame: From enrollment to end of the study.

  5. 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.

    Time frame: From enrolment to transfer to hospital at day 1

    Study assesments include: participant screening, GFAP testing with the point-of-care device, and data entry

  6. Feasibility of GFAP testing in the prehospital setting, defined as the proportion of enrolled participants in whom GFAP testing was successfully completed using the point-of-care device in the ambulance.

    Time frame: From enrolment to transfer to hospital at day 1

  7. Correlation of GFAP measurement by the point-of-care device against a laboratory assay.

    Time frame: 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.

    Time frame: From enrolment to initial CT scan up until 7 day assessment

    Exploratory outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Carcel, MD

CONTACT

[email protected]

Craig Anderson, MD

CONTACT

[email protected]

+61 4039448107

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Registry information

Official study title

INTEnsive Ambulance-delivered Blood Pressure Reduction in Biomarker-identified Hyper-ACute Intracerebral Haemorrhage Trial - Validation Study

Acronym: INTERACT4 Exp

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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