Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 4
- 主要终点
- Number of patients enrolled in the TIPITCH registry with a data completion rate ' ≥ 80% across the three main components of the registry, defined as:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of patients enrolled in the TIPITCH registry with a data completion rate ' ≥ 80% across the three main components of the registry, defined as:
时间窗: From inclusion through completion of baseline data collection (during index hospitalization)
* 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).
次要结局
- Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components:(Baseline)
- Number of stored biological samples, by sample type(Through study completion, an average of ten years)
- Completion rate of clinical follow-up data(Through study completion, an average of ten years)
- Volume of stored biological samples, by sample type(Through study completion, an average of ten years)
- Number of centralized and analyzable brain imaging studies(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).(Through study completion, an average of ten years)
- Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.(Through study completion, an average of ten years)