Intracerebral Hemorrhage
Conditions
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.
Interventions
DIAGNOSTIC_TESTLVOne
LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit
Sponsors
The George Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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 | — |
| 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 | Study assesments include: participant screening, GFAP testing with the point-of-care device, and data entry |
| 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. | From enrolment to transfer to hospital at day 1 | — |
| Correlation of GFAP measurement by the point-of-care device against a laboratory assay. | From enrolment to transfer to hospital at day 1 | — |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Exploratory outcome |
Countries
Australia
Contacts
Primary ContactCraig Anderson, MD
Backup ContactCheryl Carcel, MD
Outcome results
None listed