AI-assisted transcranial Doppler ultrasound to detect early brain bleeding
HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network
This will try to see if a quick transcranial Doppler ultrasound combined with artificial intelligence can detect intracerebral bleeding in adults with suspected acute stroke within 48 hours of symptom onset.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT07319013 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll 500 adults with suspected acute stroke who present within 48 hours of symptom onset at a single center. After the standard CT scan confirms the diagnosis, each participant will undergo a structured transtemporal transcranial Doppler ultrasound and images will be coded for research. Collected ultrasound images will be used to train and test AI models that predict whether intracerebral hemorrhage is present by comparing AI output to CT-confirmed diagnoses. There is no treatment intervention; the goal is to determine whether standardized ultrasound acquisition and AI interpretation can reliably flag haemorrhagic versus non-haemorrhagic strokes.
Who should consider this trial
Good fit: Adults (≥18 years) with a clinical diagnosis of acute stroke who present within 48 hours of symptom onset and are able to undergo transtemporal transcranial ultrasound and provide informed consent are ideal candidates.
Not a fit: Patients with infratentorial bleeds, isolated subarachnoid hemorrhage, prior craniectomy or skull defects, unstable medical status, or those who lack an adequate temporal ultrasound window are unlikely to benefit from the ultrasound-based AI approach.
Why it matters
Potential benefit: If successful, this approach could enable faster bedside identification of intracerebral hemorrhage when CT is not immediately available, improving triage and time to the right treatment.
How similar studies have performed: Smaller studies have shown transcranial ultrasound can detect some intracranial abnormalities and AI has improved image-based detection in other areas, but applying AI to transtemporal ultrasound for ICH detection is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥18 years). * Clinical diagnosis of acute stroke (ischemic or intracerebral hemorrhage). * Able to undergo transtemporal transcranial ultrasound according to the standardized protocol (no clinical instability) * Informed consent obtained from the patient or legally authorized representative, per local regulations. Exclusion Criteria: * Infratentorial hemorrhage (e.g., cerebellar or brainstem hemorrhage), due to limitations of transtemporal insonation. * Isolated subarachnoid hemorrhage without parenchymal involvement. * Hemodynamic instability or medical conditions requiring immediate life-saving intervention that preclude safe ultrasound recording. * Known skull defects or prior craniectomy on the side required for contralateral insonation. * Any condition that, in the opinion of the investigators, would interfere with protocol adherence or data accuracy.
Where this trial is running
Barcelona, Catalonia
- Hospital Universitario Vall D'Hebron — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Study coordinator: Renato Simonetti, Md
- Email: renato.simonetti@vallhebron.cat
- Phone: +34934893000
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.