About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
First brain imaging performed outside a center participating in the study (e.g., peripheral center not recruiting);
vascular malformation (aneurysm, arteriovenous malformation, cavernoma, etc.);
intracranial tumor;
hemorrhagic transformation of a cerebral infarction;
Trial population
Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number 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).
Secondary outcomes
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.
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
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
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.
Sponsors and contacts
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