Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment2000 (estimated)
SponsorIRCCS Ospedale San Raffaele
Academic / other
Locations1 site (Milan, Michigan)
StatusRecruiting
StartedMarch 13, 2024
Main results expectedDecember 31, 2028
Study endsJanuary 31, 2029
Registry record updatedNovember 4, 2026
Trial IDNCT06320132 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.