Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intracerebral Hemorrhage (ICH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of patients enrolled in the TIPITCH registry with a data completion rate ' ≥ 80% across the three main components of the registry, defined as: [Time frame: From inclusion through completion of baseline data collection (during index hospitalization)]
Secondary outcome measures (7)
- Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components: [Time frame: Baseline]
- Number of stored biological samples, by sample type [Time frame: Through study completion, an average of ten years]
- Volume of stored biological samples, by sample type [Time frame: Through study completion, an average of ten years]
- Number of centralized and analyzable brain imaging studies [Time frame: Through study completion, an average of ten years]
- Completion rate of clinical follow-up data [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). [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. [Time frame: Through study completion, an average of ten years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 4 centers
- university hospital, Angers — Angers
- university hospital, Lille — Lille
- University hospital, Toulouse — Toulouse
- University hospital — Tours
Identifiers
NCT: NCT07444853 · DR250283 - TIPITCH registries · 2025-A02143-46