Intracerebral HemorrhageINTERACT4 ExpNCT07231315
INTERACT4 Expansion - Validation Study
An observational study of Intracerebral Hemorrhage, run by The George Institute at 6 sites in Australia.
Trial summary
As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the feasibility of setting up and conducting a trial that uses a point-of-care GFAP test to identify ICH in patients presenting with acute stroke-like symptoms in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- LVOne
- How many people
- 163 participants
- Where
- 6 sitesAustralia
- Study dates
- 18 Sep 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected acute stroke presenting to ambulance services
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cheryl Carcel, MD contact
6 sites in 1 country
Australia6 sites, 6 recruiting
- Not yet recruiting
Liverpool Hospital
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
Dennis Cordato
- Recruiting
Nepean Hospital
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
Sameen Haque
- Recruiting
New South Wales Ambulance
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
David Patterson
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
Christopher Partyka
- Recruiting
St George Hospital
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
Stephen Asha
- Recruiting
Wollongong Hospital
Sydney, New South Wales
Cheryl Carcel, +61 2 8052 4508, ccarcel@georgeinstitute.org.au
Kate Curtis
About this study
Official title: INTEnsive Ambulance-delivered Blood Pressure Reduction in Biomarker-identified Hyper-ACute Intracerebral Haemorrhage Trial - Validation Study
As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the feasibility of setting up and conducting a trial that uses a point-of-care GFAP test to identify ICH in patients presenting with acute stroke-like symptoms in the pre-hospital setting.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- LVOne
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVOneDiagnostic test
LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment, assessed by the proportion of enrolled participants over the number of stroke calls in the participating networks during the study period.
Measured: Through study completion, an average of 1 year
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.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: Baseline
Proportion of participants without ICH on hospital-based brain CT who are correctly identified as negative based on GFAP point-of-care measurement. (Specificity)
Measured: Day 7
Proportion of participants with ICH on hospital-based brain CT who are correctly identified as positive based on GFAP point-of-care measurement. (Sensitivity)
Measured: Day 7
Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT. (Positive predictive value)
Measured: Day 7
Proportion of participants with a negative GFAP point-of-care measurement who are confirmed to not have an ICH on hospital-based brain CT. (Negative predictive value)
Measured: From enrolment to initial CT scan up until 7 day assessment
Correlation of GFAP measurement by the point-of-care device against a laboratory assay.
Measured: From enrolment to transfer to hospital at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start18 Sep 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231315
- Sponsor's protocol ID
- P01720
- Acronym
- INTERACT4 Exp
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEnsive Ambulance-delivered Blood Pressure Reduction in Biomarker-identified Hyper-ACute Intracerebral Haemorrhage Trial - Validation Study
- ClinicalTrials.gov ID
- NCT07231315
- Acronym / sponsor ID
- INTERACT4 Exp / P01720
- Conditions
- Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the feasibility of setting up and conducting a trial that uses a point-of-care GFAP test to identify ICH in patients presenting with acute stroke-like symptoms in the pre-hospital setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected acute stroke presenting to ambulance services
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVOneLVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit | Diagnostic test | – |
Primary outcome
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: Through study completion, an average of 1 year
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: Baseline
6 secondary outcomes
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: Baseline
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: Day 7
Proportion of participants with ICH on hospital-based brain CT who are correctly identified as positive based on GFAP point-of-care measurement. (Sensitivity)
Time frame: Day 7
Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT. (Positive predictive value)
Time frame: Day 7
Proportion of participants with a negative GFAP point-of-care measurement who are confirmed to not have an ICH on hospital-based brain CT. (Negative predictive value)
Time frame: From enrolment to initial CT scan up until 7 day assessment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryl Carcel, MD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by The George Institute at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Anderson, MD (+61 4039448107, canderson@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.