INTERACT4 Expansion - Validation Study

N/ANot Yet RecruitingNCT07231315

The George Institute465 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

465

Conditions

Intracerebral Hemorrhage

Interventions

LVOneDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Liverpool Hospital

Sydney, New South Wales, Australia

Nepean Hospital

Sydney, New South Wales, Australia

New South Wales Ambulance

Sydney, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

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

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

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

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

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.

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.

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

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

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.

Central Contacts

Craig Anderson, MD

CONTACT

+61 4039448107 canderson@georgeinstitute.org.au

Cheryl Carcel, MD

CONTACT

ccarcel@georgeinsitute.org.au

Data from ClinicalTrials.gov

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