NCT07444853

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, multicenter national cohort study in ICH is designed to support comprehensive clinical, biological, imaging, and process-of-care characterization of patients. A centralized and harmonized biobank will be established to enable the collection and analysis of biological samples, with a focus on biomarkers related to inflammation, hematoma resorption, and genetic susceptibility. A standardized and interoperable imaging database will be implemented to allow quantitative analysis of hemorrhagic lesions, including hematoma volume, hematoma expansion, perihematomal edema, and their temporal evolution over time. The study will also document acute ICH management practices, including the proportion of patients managed according to the evidence-based care bundle validated in the INTERACT 3 study. Components of this bundle include early intensive blood pressure control, reversal of anticoagulation when applicable, maintenance of blood glucose within recommended targets, body temperature control, and systematic neurosurgical consultation. Adherence to these components will be recorded as part of routine care. The cohort will rely on a network of participating clinical and research centers trained and equipped to apply standardized procedures for patient inclusion, data collection, imaging acquisition, and biospecimen handling, with the objective of promoting harmonized clinical practice and high-quality data generation. Finally, the cohort is intended to serve as a structured platform to support the design and implementation of future stratified interventional clinical trials in spontaneous ICH, based on phenotypic, biomarker, imaging, and care-process data generated within the cohort.

Conditions

• Intracerebral Hemorrhage (ICH)

Timeline

• Start date: 2026-02-01
• Primary completion: 2036-02-01
• Completion: 2036-02-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

4 sites across 1 country: France