Improving prognosis after spontaneous intracerebral hemorrhage using clinical, blood, and imaging markers

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

This project will try combining clinical data, blood samples, and brain scans to find markers that predict outcomes for adults admitted with spontaneous intracerebral hemorrhage.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Tours (other)
• Locations: 4 sites (Angers and 3 other locations)
• Trial ID: NCT07444853 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter national cohort enrolling adults with spontaneous intracerebral hemorrhage to collect standardized clinical, biological, and imaging data. A centralized, harmonized biobank will store samples aimed at biomarkers of inflammation, hematoma resorption, and genetic susceptibility. An interoperable imaging database will enable quantitative measures such as hematoma volume, expansion, and perihematomal edema and track their evolution over time. The protocol also documents acute care practices, including adherence to the INTERACT-3 care bundle, and is intended as a platform for translational work and preparation of future stratified interventional trials.

Who should consider this trial

Good fit: Adults (age ≥18) who are emergently admitted to a participating center with spontaneous intracerebral hemorrhage confirmed by the first in-hospital CT or MRI and who can provide non-opposition to participation are ideal candidates.

Not a fit: Patients whose hemorrhage is secondary to a known cause (for example vascular malformation, tumor, hemorrhagic infarct, or recent head trauma), those imaged first at non-participating centers, or those under legal protection/guardianship are not eligible and unlikely to benefit from this cohort.

Why it matters

Potential benefit: If successful, the work could help clinicians identify patients at higher risk earlier and guide more personalized acute and follow-up care to improve outcomes.

How similar studies have performed: Evidence-based care bundles such as INTERACT-3 have shown benefit for early blood-pressure and general acute care management, but using combined clinical, biological, and imaging biomarkers for prognostic stratification remains an emerging approach with limited widescale validation.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Angers and 3 other locations

• university hospital, Angers — Angers, France (NOT_YET_RECRUITING)
• university hospital, Lille — Lille, France (NOT_YET_RECRUITING)
• University hospital, Toulouse — Toulouse, France (NOT_YET_RECRUITING)
• University hospital — Tours, France (RECRUITING)

Study contacts

• Study coordinator: Marco PASI, Pr

Conditions: Intracerebral Hemorrhage, diagnostic and prognostic biomarkers