Rapid blood test using GFAP to tell hemorrhagic vs ischemic stroke
Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
This project will test whether a quick blood test for GFAP can tell if adults with suspected stroke have bleeding in the brain when they arrive within three hours of symptom onset.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 527 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07003477 on ClinicalTrials.gov |
What this trial studies
This observational cohort will enroll adults with suspected stroke who present within three hours and collect peripheral blood to measure GFAP and other biomarkers. The project partners hospitals with industry to develop and validate a rapid diagnostic workflow aimed at pre-hospital and emergency use. Results will be compared to clinical imaging to determine how well the biomarker distinguishes intracerebral hemorrhage from ischemic stroke. The goal is to produce data that could support faster, guided treatment decisions in the ambulance or emergency department.
Who should consider this trial
Good fit: Adults aged 18 or older who arrive with suspected stroke (FAST score ≥2 including limb weakness) within three hours of symptom onset are ideal candidates for this project.
Not a fit: Patients in coma, with severe comorbidities that limit daily living, recent head trauma, seizure-onset strokes, or very low blood glucose are excluded and may not benefit from this protocol.
Why it matters
Potential benefit: If successful, the test could allow clinicians to identify intracerebral hemorrhage quickly and start appropriate treatments sooner, potentially improving outcomes.
How similar studies have performed: Prior clinical work has shown GFAP is highly specific for intracerebral hemorrhage and trials like INTERACT4 demonstrated benefit of very early blood-pressure lowering, but deploying GFAP as a rapid pre-hospital diagnostic tool is a newer application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Suspected stroke at emergency department arrival (FAST score ≥ 2 points, must include limb weakness); 3. Time of stroke symptom onset/last known normal within 3 hours. Exclusion Criteria: 1. Coma - no response to tactile or verbal stimuli; 2. Severe comorbidities (such as tumors, severe COPD, severe heart failure, requiring assistance with daily living \[unable to walk independently\]); 3. History of epilepsy or onset with seizure; 4. Recent history of head trauma (\< 7 days); 5. Blood glucose \< 2.8 mmol/L.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Gang Li
- Email: ligang@tongji.edu.cn
- Phone: +86 136 2169 1786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.