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

NCT06320132 | Recruiting

• 1 other identifier: BLANDISH
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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, and anamnesis. Participants will be treated as per standard clinical practice.

Conditions

Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (1)

• Mortality

  Patients who die within 12 months after being treated for spontaneous intracranial hemorrhage

  12 months

Study Arms (2)

Retrospective group

Patients treated for spontaneous intracranial hemorrhage before March 13, 2024.

Other: Treatment of spontaneous intracranial hemorrhage

Prospective group

Patients treated for spontaneous intracranial hemorrhage after March 13, 2024.

Other: Treatment of spontaneous intracranial hemorrhage

Interventions

Treatment of spontaneous intracranial hemorrhage OTHER

Data collection of therapeutic approach, including radiological, medical, surgical therapies.

Prospective group; Retrospective group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients affected by spontaneous Intracranial Hemorrhage.

You may qualify if:

• Patients who enter the NICU for acute spontaneous intracranial hemorrhage
• Adult patients (≥ 18 years)
• Sex: female, male, intersex

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, Italy

RECRUITING

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca Guzzo, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Guzzo, MD

CONTACT

+393470830669; guzzo.francesca@hsr.it

Margherita Tozzi, MD

CONTACT

+393343138755; tozzi.margherita@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)