- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320132
BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage) (BLANDISH)
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
The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.
Participants will be treated as per standard clinical practice.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In NeuroICU, treatments typically adhere to guidelines based on scientific consensus. Despite this, the prognosis for patients with intracranial hemorrhages has not significantly improved over recent decades, resulting in generally unsatisfactory outcomes. While randomized controlled trials (RCTs) are considered the gold standard for clinical research, they can be expensive and ethically challenging to conduct. Observational studies provide an alternative method, offering larger datasets covering longer periods, which can be more beneficial and feasible for certain research endeavors.
Machine Learning (ML) algorithms, unlike classical statistical methods, have the capability to process a vast number of variables, offering a personalized and dependable approach for healthcare providers in patient management. Recognizing the necessity for well-designed studies to identify optimal therapeutic strategies for neurocritical patients and acknowledging the limitations of existing guidelines, we aim to leverage ML programs to develop an advanced system capable of uncovering data patterns and linking them to potential outcomes.
The BLANDISH project focuses on patients with spontaneous intracerebral hemorrhage (sICH), a condition lacking proven beneficial treatment. By collecting and analyzing data from sICH patients admitted to neuroICU, the project aims to develop a supervised ML algorithm named BLANDISH.
This algorithm will stratify patients based on prognosis, identifying those at highest risk of death and secondary brain injuries. By guiding each patient towards the most targeted therapeutic strategy, the algorithm could help improve patient outcomes and assess the effectiveness of current clinical practices. Additionally, it may enable healthcare staff to better allocate resources and introduce individualized therapeutic programs based on precision medicine, potentially reducing hospitalization times and healthcare costs.
The initial step in developing the BLANDISH algorithm involves collecting clinical data, stored in a structured datalake, which serves as a data repository. This platform will gather information on the clinical course of sICH patients admitted to neuroICU. After data collection, the next steps include preprocessing, variable selection correlated with patient mortality, and algorithm training with input data and internal validation to control its behavior. External validation will follow, involving data collection from various clinical centers to assess the algorithm's reliability and generalization capacity. A multicenter observational clinical study will then be conducted to validate the BLANDISH algorithm, aiming to determine its impact on sICH patient outcomes. This final phase includes a survival study comparing patients in the experimental group (whose treatment is guided by BLANDISH) with those following standard clinical practice. The project aims to demonstrate the superiority of the ML approach over current guidelines, evaluating the accuracy and potential improvements in patient management across different care settings.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francesca Guzzo, MD
- Phone Number: +390226433333 +393470830669
- Email: guzzo.francesca@hsr.it
Study Contact Backup
- Name: Margherita Tozzi, MD
- Phone Number: +390226433333 +393343138755
- Email: tozzi.margherita@hsr.it
Study Locations
-
-
MI
-
Milano, MI, Italy
- Recruiting
- IRCCS Ospedale San Raffaele
-
Contact:
- Francesca Guzzo, MD
- Phone Number: +390226433333 +393470830669
- Email: guzzo.francesca@hsr.it
-
Contact:
- Margherita Tozzi, MD
- Phone Number: +390226433333 +393343138755
- Email: tozzi.margherita@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retrospective group
Patients treated for spontaneous intracranial hemorrhage before March 13, 2024.
|
Data collection of therapeutic approach, including radiological, medical, surgical therapies.
|
Prospective group
Patients treated for spontaneous intracranial hemorrhage after March 13, 2024.
|
Data collection of therapeutic approach, including radiological, medical, surgical therapies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 12 months
|
Patients who die within 12 months after being treated for spontaneous intracranial hemorrhage
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francesca Guzzo, MD, IRCCS Ospedale San Raffaele
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BLANDISH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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