Machine learning analysis of spontaneous intracranial hemorrhage outcomes
Official title: BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage): Design and Internal Validation of an AI System to Support and Optimize the Management of Spontaneous Intracranial Hemorrhage Patients in the NeuroICU
Run by IRCCS Ospedale San Raffaele · NCT06320132 · Data updated 2026-11-12
This study is testing a new computer program that uses patient data to see if it can help doctors better understand and predict outcomes for people with spontaneous brain bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Michigan) |
| Status | Recruiting |
| Started | March 13, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | January 31, 2029 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06320132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients (≥ 18 years) admitted to the NeuroICU for acute spontaneous intracranial hemorrhage.
✕Probably not a fit
Patients with non-spontaneous intracranial hemorrhage, chronic ICH, or those with sICH due to brain tumors or metastases will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to train a machine learning system using data from patients with spontaneous intracranial hemorrhage (sICH) to identify correlations between clinical practices, outcomes, and predictive factors. Participants will receive standard clinical care while their data is collected and analyzed to develop a supervised machine learning algorithm named BLANDISH. This algorithm seeks to stratify patients based on prognosis and improve understanding of treatment strategies for neurocritical patients. The study addresses the limitations of existing guidelines and aims to uncover data patterns linked to patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved patient management and outcomes for those suffering from spontaneous intracranial hemorrhage.
How similar studies have gone: While observational studies in this area are common, the use of machine learning for this specific purpose is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who enter the NICU for acute spontaneous intracranial hemorrhage * Adult patients (≥ 18 years) * Sex: female, male, intersex Exclusion Criteria: * All patients affected by non-spontaneous ICH * Patients with sICH determined by brain tumor or brain metastases * All patients affected by chronic ICH * Pregnant and puerperal women * Refusal to participate in the protocol
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Michigan, Italy Recruiting
Study contacts
- Principal investigator: Francesca Guzzo, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Francesca Guzzo, MD
- Email: guzzo.francesca@hsr.it
- Phone: +393470830669
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.