Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVOne | Diagnostic Test | LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Exploratory outcome | From enrolment to initial CT scan up until 7 day assessment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with suspected acute stroke presenting to ambulance services
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Anderson, MD | Contact | +61 4039448107 | canderson@georgeinstitute.org.au | |
| Cheryl Carcel, MD | Contact | ccarcel@georgeinsitute.org.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Sydney | New South Wales | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. |
| 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 | 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. | 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 |
| 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 |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |