Actively Recruiting

Age: 18Years +
All Genders
ID06320132

BLANDISH: Design and Internal Validation of an AI System to Support and Optimize Management of Spontaneous Intracranial Hemorrhage Patients in the NeuroICU

Led by IRCCS Ospedale San Raffaele · Updated on 2025-04-06

2000

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates spontaneous intracranial hemorrhage (sICH), focusing on developing a machine learning (ML) system to analyze clinical data and predict patient outcomes. Researchers aim to identify links between actual clinical practice, patient results, and predictive factors to improve management of sICH patients in neuro-intensive care units. This observational study is sponsored by IRCCS Ospedale San Raffaele and addresses the limited progress in treatment outcomes for sICH despite existing guidelines. Participants are observed under standard clinical care, with data collected on therapeutic approaches including radiological, medical, and surgical treatments. The study includes two groups: retrospective patients treated before March 13, 2024, and prospective patients treated after this date. The collected data will be used to develop and validate the BLANDISH ML algorithm, which aims to stratify patient risk and support personalized therapeutic strategies. During the study, researchers will gather detailed clinical data stored in a structured database to train and validate the ML system. They will monitor mortality over 12 months as the primary outcome to assess the algorithm's predictive accuracy and potential impact on patient management. This study involves ongoing data collection and analysis, aiming to enhance treatment decisions and healthcare resource use for sICH patients.

CONDITIONS

Brief Title

BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to the neuro-intensive care unit for acute spontaneous intracranial hemorrhage
  • Adults aged 18 years or older
  • All genders: female, male, intersex
Not Eligible

You will not qualify if you...

  • Patients with non-spontaneous intracranial hemorrhage
  • Patients with sICH caused by brain tumor or metastases
  • Patients with chronic intracranial hemorrhage
  • Pregnant or postpartum women
  • Patients who refuse to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 months

Clinical data are collected from patients admitted to the neuro-intensive care unit with spontaneous intracranial hemorrhage to support algorithm development.

Visits as part of routine clinical care

Long-term Monitoring

Duration - Up to 12 months

Participants are observed for outcomes including mortality up to 12 months post initial treatment to validate the machine learning algorithm.

Follow-up visits aligned with standard care schedules

Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Actively Recruiting

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Research Team

F

Francesca Guzzo, MD

M

Margherita Tozzi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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