INTERACT4 Expansion - Validation Study

Official title

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

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.

Interventions

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

Primary outcome measures

• 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 outcome measures (7)

• 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. [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. [Time frame: From enrolment to transfer to hospital at day 1]
• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Australia · 4 centers

• Liverpool Hospital — Sydney
• Nepean Hospital — Sydney
• New South Wales Ambulance — Sydney
• Royal North Shore Hospital — Sydney

Identifiers

NCT: NCT07231315 · P01720

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗