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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02143-46 | Other Identifier | IDRCB |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients enrolled in the TIPITCH registry with a data completion rate ' ≥ 80% across the three main components of the registry, defined as: |
| From inclusion through completion of baseline data collection (during index hospitalization) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components: |
|
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Inclusion Criteria:
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:
Patient under legal protection;
Patient under guardianship or conservatorship.
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Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco PASI, Pr | Contact | 2.47.47.80.21 | +33 | m.pasi@chu-tours.fr |
| Sophie QUERAUD | Contact | 247470156 | +33 | s.queraud@chu-tours.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital, Angers | Not yet recruiting | Angers | 49000 | France |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Blood samples
| 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 | 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 | 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. | 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. | 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). | 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. | Through study completion, an average of ten years |
| university hospital, Lille | Not yet recruiting | Lille | 59000 | France |
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| University hospital, Toulouse | Not yet recruiting | Toulouse | 31000 | France |
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| University hospital | Recruiting | Tours | 37000 | France |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |