Intracranial HemorrhagesBLANDISHNCT06320132
BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)
An observational study of Intracranial Hemorrhages, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Treatment of spontaneous intracranial hemorrhage
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2024to 31 Jan 2029
- How long will I take part?
- 14 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients affected by spontaneous Intracranial Hemorrhage.
Who may be able to join
- Patients who enter the NICU for acute spontaneous intracranial hemorrhage
- Adult patients (≥ 18 years)
- Sex: female, male, intersex
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Michigan
Francesca Guzzo, MD, +393470830669 ext. +390226433333, guzzo.francesca@hsr.it
Marilena Marmiere, MD, +393402124464 ext. +390226433333, marmiere.marilena@hsr.it
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Hemorrhages
- Being tested
- Treatment of spontaneous intracranial hemorrhage
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of spontaneous intracranial hemorrhageOther
Data collection of therapeutic approach, including radiological, medical, surgical therapies.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | Patients treated for spontaneous intracranial hemorrhage before March 13, 2024. Receives: Other: Treatment of spontaneous intracranial hemorrhage | |
| Prospective group | Patients treated for spontaneous intracranial hemorrhage after March 13, 2024. Receives: Other: Treatment of spontaneous intracranial hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients who die within 12 months after being treated for spontaneous intracranial hemorrhage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 Mar 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 14 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Guzzo, IRCCS Ospedale San Raffaele
- Investigators
- Francesca Guzzo, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320132
- Sponsor's protocol ID
- BLANDISH
- Acronym
- BLANDISH
- Status last verified
- Nov 2026
- First submitted
- 13 Mar 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06320132
- Acronym / sponsor ID
- BLANDISH / BLANDISH
- Conditions
- Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | – | Other: Treatment of spontaneous intracranial hemorrhagePatients treated for spontaneous intracranial hemorrhage before March 13, 2024. |
| Prospective group | – | Other: Treatment of spontaneous intracranial hemorrhagePatients treated for spontaneous intracranial hemorrhage after March 13, 2024. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients affected by spontaneous Intracranial Hemorrhage.
Key inclusion criteria (3 listed)
- Patients who enter the NICU for acute spontaneous intracranial hemorrhage
- Adult patients (≥ 18 years)
- Sex: female, male, intersex
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of spontaneous intracranial hemorrhageData collection of therapeutic approach, including radiological, medical, surgical therapies. | Other | Prospective group, Retrospective group |
Primary outcome
Mortality
Time frame: 12 months
Patients who die within 12 months after being treated for spontaneous intracranial hemorrhage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Guzzo, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Guzzo, MD (+393470830669 ext. +390226433333, guzzo.francesca@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.