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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,000
university hospital, Angers
Angers, France
NOT_YET_RECRUITINGuniversity hospital, Lille
Lille, France
NOT_YET_RECRUITINGUniversity hospital, Toulouse
Toulouse, France
NOT_YET_RECRUITINGUniversity hospital
Tours, France
RECRUITINGNumber 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).
Time frame: From inclusion through completion of baseline data collection (during index hospitalization)
Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components:
* Early intensive blood pressure control; * Reversal of anticoagulation when applicable; * Maintenance of blood glucose within recommended targets (6.1-7.8 mmol/L for non-diabetic patients; 7.8-10.0 mmol/L for diabetic patients); * Body temperature \< 37.5 °C within one hour of hospital admission; * Systematic neurosurgical consultation.
Time frame: Baseline
Number of stored biological samples, by sample type
Number of stored biological samples, by sample type (including citrated plasma, heparinized plasma, serum, DNA) and meeting predefined quality criteria
Time frame: Through study completion, an average of ten years
Volume of stored biological samples, by sample type
Volume of stored biological samples, by sample type (including citrated plasma, heparinized plasma, serum, DNA) and meeting predefined quality criteria
Time frame: Through study completion, an average of ten years
Number of centralized and analyzable brain imaging studies
Number of centralized and analyzable brain imaging studies, by imaging modality (CT, MRI), sequences, and availability of associated metadata.
Time frame: Through study completion, an average of ten years
Completion rate of clinical follow-up data
Completion rate of clinical follow-up data, including the modified Rankin Scale (mRS), at 3, 6, and 24 months after intracerebral hemorrhage.
Time frame: Through study completion, an average of ten years
Number of participating centers achieving a data collection quality level > 80% across the three registry components (clinical, imaging, and biological data).
Number of participating centers achieving a data collection quality level \> 80% across the three registry components (clinical, imaging, and biological data).
Time frame: Through study completion, an average of ten years
Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.
Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.
Time frame: Through study completion, an average of ten years
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