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

April 29, 2026 updated by: University Hospital, Tours

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49000
        • Not yet recruiting
        • University Hospital, Angers
        • Contact:
        • Principal Investigator:
          • Sophie GODARD, Dr
      • Lille, France, 59000
        • Not yet recruiting
        • University Hospital, Lille
        • Contact:
        • Principal Investigator:
          • Charlotte CORDONNIER, Pr
      • Toulouse, France, 31000
        • Not yet recruiting
        • University Hospital, Toulouse
        • Contact:
        • Principal Investigator:
          • Nicolas RAPOSO, Pr
      • Tours, France, 37000
        • Recruiting
        • University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco PASI, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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:
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).
From inclusion through completion of baseline data collection (during index hospitalization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
Through study completion, an average of ten years
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
Through study completion, an average of ten years
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.
Through study completion, an average of ten years
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.
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).
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).
Through study completion, an average of ten years
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.
Through study completion, an average of ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2026

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

April 1, 2036

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR250283 - TIPITCH registries
  • 2025-A02143-46 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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