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NCT Number: NCT07444853

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

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.

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Key information

Conditions

Intracerebral Hemorrhage (ICH) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Disease Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

university hospital, Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

    Time frame: 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).

Secondary outcomes

  1. Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components:

    Time frame: Baseline

    • 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.

  2. Number of stored biological samples, by sample type

    Time frame: Through study completion, an average of ten years

    Number of stored biological samples, by sample type (including citrated plasma, heparinized plasma, serum, DNA) and meeting predefined quality criteria

  3. Volume 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 (including citrated plasma, heparinized plasma, serum, DNA) and meeting predefined quality criteria

  4. Number of centralized and analyzable brain imaging studies

    Time frame: Through study completion, an average of ten years

    Number of centralized and analyzable brain imaging studies, by imaging modality (CT, MRI), sequences, and availability of associated metadata.

  5. Completion rate of clinical follow-up data

    Time frame: Through study completion, an average of ten years

    Completion rate of clinical follow-up data, including the modified Rankin Scale (mRS), at 3, 6, and 24 months after intracerebral hemorrhage.

  6. 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 participating centers achieving a data collection quality level > 80% across the three registry components (clinical, imaging, and biological data).

  7. 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

    Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco PASI, Pr

CONTACT

[email protected]

2.47.47.80.21 ext. +33

Sophie QUERAUD

CONTACT

[email protected]

247470156 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: TIPITCH

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Mar 3, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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