Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers

NCT07444853 | Recruiting

• 2 other identifiers: DR250283 - TIPITCH registries2025-A02143-46
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 4

Brief Summary

This study will establish a prospective, multicenter national cohort of patients with spontaneous intracerebral hemorrhage (ICH). A standardized multimodal database integrating clinical, biological, and imaging data will be collected. The study aims to better characterize ICH patient phenotypes, identify diagnostic and prognostic biomarkers, and describe adherence to evidence-based acute management strategies, including the proportion of patients managed according to the care bundle validated in the INTERACT 3 study. The cohort is also intended to provide a structured platform for translational research and the preparation of future stratified interventional clinical trials in spontaneous ICH.

Conditions

Intracerebral Hemorrhage (ICH)

Keywords

diagnostic and prognostic biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of patients enrolled in the TIPITCH registry with a data completion rate ' ≥ 80% across the three main components of the registry, defined as:

  * Clinical data (sociodemographic characteristics, medical history, clinical examination, severity scores, and treatments); * Imaging data (at least one centralized and analyzable neuroimaging examination); * Biological data (at least one biological sample centralized in the biobank according to predefined quality standards).

  From inclusion through completion of baseline data collection (during index hospitalization)

Secondary Outcomes (7)

• Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components:

  Baseline

• Number of stored biological samples, by sample type

  Through study completion, an average of ten years

• Volume of stored biological samples, by sample type

  Through study completion, an average of ten years

• Number of centralized and analyzable brain imaging studies

  Through study completion, an average of ten years

• Completion rate of clinical follow-up data

  Through study completion, an average of ten years

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

Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.

You may qualify if:

• Age ≥ 18 years;
• Emergency admission to a participating center, with spontaneous intracerebral hemorrhage confirmed by the first brain imaging (CT or MRI) performed at the time of initial treatment;
• Obtaining non-opposition

You may not qualify if:

• First brain imaging performed outside a center participating in the study (e.g., peripheral center not recruiting);
• Intracerebral hemorrhage secondary to another identified condition, including:
• vascular malformation (aneurysm, arteriovenous malformation, cavernoma, etc.);
• intracranial tumor;
• hemorrhagic transformation of a cerebral infarction;
• recent head trauma.
• Patient under legal protection;
• Patient under guardianship or conservatorship.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

university hospital, Angers

Angers, 49000, France

NOT YET RECRUITING

university hospital, Lille

Lille, 59000, France

NOT YET RECRUITING

University hospital, Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

University hospital

Tours, 37000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Cerebral Hemorrhage; Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marco PASI, Pr

CONTACT

2.47.47.80.21; m.pasi@chu-tours.fr

Sophie QUERAUD

CONTACT

247470156; s.queraud@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 3, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): April 1, 2036
• Study Completion (Estimated): April 1, 2036
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (4)