Machine learning analysis of spontaneous intracranial hemorrhage outcomes
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
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06320132 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients (≥ 18 years) admitted to the NeuroICU for acute spontaneous intracranial hemorrhage.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, MI
- IRCCS Ospedale San Raffaele — Milan, Mi, 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
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.