Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

Patients with suspected acute stroke presenting to ambulance services

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • LVOne

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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.

Other outcomes

1

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

Time frame
From enrolment to initial CT scan up until 7 day assessment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: