Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
From inclusion through completion of baseline data collection (during index hospitalization)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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