INTERACT4 Expansion - Validation Study
ConditionIntracerebral Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe George Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- LVOne
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov