Intracerebral Hemorrhage (ICH)TIPITCHNCT07444853
Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers
An observational study of Intracerebral Hemorrhage (ICH), run by University Hospital, Tours at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage (ICH)
- How many people
- 10,000 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Apr 2026to Apr 2036
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
university hospital, Angers
Angers, 49000
Sophie GODARD, Dr, 241353591 ext. +33, sogodard@chu-angers.fr
Sophie GODARD, Dr
- Not yet recruiting
university hospital, Lille
Lille, 59000
Charlotte CORDONNIER, Pr, 3.20.44.68.14 ext. +33, charlotte.cordonnier@chu-lille.fr
Charlotte CORDONNIER, Pr
- Not yet recruiting
University hospital, Toulouse
Toulouse, 31000
Nicolas RAPOSO, Pr, 561779486 ext. +33, raposo.n@chu-toulouse.fr
Nicolas RAPOSO, Pr
- Recruiting
University hospital
Tours, 37000
Marco PASI, Pr, 2.47.47.80.21 ext. +33, m.pasi@chu-tours.fr
Sophie QUERAUD, 247470156 ext. +33, s.queraud@chu-tours.fr
About this study
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage (ICH)
- Keywords
- diagnostic and prognostic biomarkers
- Medical subject headings
- Cerebral Hemorrhage, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From inclusion through completion of baseline data collection (during index hospitalization)
Secondary outcomes (7)
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.
Measured: Baseline
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
Measured: Through study completion, an average of ten years
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
Measured: Through study completion, an average of ten years
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.
Measured: Through study completion, an average of ten years
Completion rate of clinical follow-up data
Completion rate of clinical follow-up data, including the modified Rankin Scale (mRS), at 3, 6, and 24 months after intracerebral hemorrhage.
Measured: 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).
Number of participating centers achieving a data collection quality level > 80% across the three registry components (clinical, imaging, and biological data).
Measured: Through study completion, an average of ten years
Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.
Number of research projects initiated or scientific publications produced using data from the TIPITCH registry.
Measured: Through study completion, an average of ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start9 Apr 2026
- Primary completionApr 2036 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage (ICH)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444853
- Sponsor's protocol ID
- DR250283 - TIPITCH registries
- Other IDs
- 2025-A02143-46
- Acronym
- TIPITCH
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers
- ClinicalTrials.gov ID
- NCT07444853
- Acronym / sponsor ID
- TIPITCH / DR250283 - TIPITCH registries
- Conditions
- Intracerebral Hemorrhage (ICH)
- Keywords
- diagnostic and prognostic biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- Apr 2036 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with spontaneous intracerebral hemorrhage included in 4 centers.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- Patient under legal protection;
- Patient under guardianship or conservatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
Proportion of patients managed according to the care bundle validated in the INTERACT 3 study, including the following components:
Time frame: Baseline
Number 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
Time frame: 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
Completion rate of clinical follow-up 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).
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.
Time frame: Through study completion, an average of ten years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Intracerebral Hemorrhage (ICH)
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Recruiting
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
Intracerebral Hemorrhage
Not yet recruiting
REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH.
Intracerebral Hemorrhage
RecruitingObservational study
The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
Intracerebral Haemorrhage (ICH), Cerebral Infarction
Recruiting
Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
Basal Ganglia Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage (ICH), run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco PASI, Pr (2.47.47.80.21 ext. +33, m.pasi@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.