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ClinicalTrials.gov ID

NCT07231315

Lead Sponsor

The George InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

465Estimated

Last Update Posted

Nov 19, 2025Actual

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

Official Title

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

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.

• Intracerebral Hemorrhage

• LVOne

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

The George InstituteOTHER

ccarcel@georgeinstitute.org.au+61 2 8052 4508