Intracerebral HemorrhageMIMICK-TIPITCHNCT07411079
Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator for Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage and Hemorrhagic Risk Conditions, run by University Hospital, Lille at 1 site in France.
Trial summary
Intracerebral hemorrhage (ICH) is associated with high mortality and long-term disability, and effective treatment options remain limited. Minimally invasive surgical approaches combined with local administration of thrombolytic agents have been investigated to facilitate hematoma evacuation; however, incomplete clot… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage, Hemorrhagic Risk Conditions, Bleeding Disorders
- What is being tested?
- Ex vivo exposure to modified rtPA
- How many people
- 1,126 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2026to Mar 2029
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults receiving routine outpatient care who are either without hemorrhagic risk or have predefined hemorrhagic risk profiles, including antithrombotic treatment, inherited bleeding disorders, thrombocytopenia, or conditions requiring reversal or correction of coagulation abnormalities, and who consent to a single blood sample collection.
Who may be able to join
- Adult participants (≥ 18 years of age)
- Able and willing to provide written informed consent
- Receiving routine outpatient care
- Either:
- Without identified hemorrhagic risk (control subjects)
- With a predefined hemorrhagic risk profile, including antithrombotic treatment, inherited bleeding disorders, thrombocytopenia or conditions requiring reversal or correction of coagulation abnormalities
- Able to undergo a single additional whole blood collection (30 mL) during a routine clinical visit
Who cannot join
- Age < 18 years
- Inability or unwillingness to provide written informed consent
- Contraindication to venipuncture or blood sampling
- Known human immunodeficiency virus (HIV) infection
- Breastfeeding
- Presence of an additional coagulation abnormality not related to the identified hereditary bleeding disorder or the antithrombotic treatment under study
- Individuals deprived of liberty by judicial or administrative decision
- Individuals under legal protection (guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59000
Mélanie DANIEL, Dr, 03.20.44.59.62, melanie.daniel@hu-lille.fr
About this study
Official title: Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator to Improve Parenchymal Clearance in Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) is associated with high mortality and long-term disability, and effective treatment options remain limited. Minimally invasive surgical approaches combined with local administration of thrombolytic agents have been investigated to facilitate hematoma evacuation; however, incomplete clot removal remains frequent, particularly in patients with conditions associated with increased hemorrhagic risk.
This observational, cross-sectional study uses an ex vivo model of clinically sized intracerebral hematomas generated from whole blood samples collected from control subjects without hemorrhagic risk and from individuals with predefined hemorrhagic risk profiles, including conditions associated with antithrombotic treatment, inherited bleeding disorders, thrombocytopenia and situations involving reversal or correction of coagulation abnormalities.
Read more
Using standardized ex vivo hematoma formation and catheter-based administration of modified Tissue Plasminogen Activator (rtPA), the study will characterize clot structure, composition, and permeability across hemorrhagic risk conditions. The study will then determine personalized dosing regimens of modified rtPA in conditions where thrombolytic activity differs from reference values observed in healthy control samples treated with a standard dose. Finally, the thrombolytic activity of personalized dosing regimens will be evaluated by measuring hematoma weight reduction 9 hours after treatment and compared with predefined efficacy and safety reference boundaries.
The results of this study are intended to improve understanding of the ex vivo thrombolytic performance of modified rtPA across different hemorrhagic risk contexts and to support future translational and clinical research in intracerebral hemorrhage.
- Being tested
- Ex vivo exposure to modified rtPA
- Keywords
- Intracranial Hemorrhages, Hematoma Lysis, Modified Tissue Plasminogen Activator, Bleeding Disorders, Antithrombotic Therapy, Ex vivo Model
- Medical subject headings
- Cerebral Hemorrhage, Hemostatic Disorders, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo exposure to modified rtPAOther
No intervention is administered to participants. Modified rtPA is applied exclusively ex vivo to anonymized blood-derived hematoma samples generated after biospecimen collection, for experimental evaluation of thrombolytic activity.
| Study group | Role | What they receive |
|---|---|---|
| Biospecimen donors | Participants will undergo a single whole blood collection (30 mL) during a routine clinical visit. No investigational medicinal product is administered to participants.
Collected blood samples will be anonymized and used ex vivo to generate clinically sized intracerebral hematomas, which will subsequently be exposed to rtPA for experimental analysis. Receives: Other: Ex vivo exposure to modified rtPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma Lysis Rate
Measured: 9 hours after ex vivo administration of rtPA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start2 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélanie Daniel, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411079
- Sponsor's protocol ID
- 2025_0168
- Other IDs
- 2025-A02187-42
- Acronym
- MIMICK-TIPITCH
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator to Improve Parenchymal Clearance in Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT07411079
- Acronym / sponsor ID
- MIMICK-TIPITCH / 2025_0168
- Keywords
- Intracranial Hemorrhages, Hematoma Lysis, Modified Tissue Plasminogen Activator, Bleeding Disorders, Antithrombotic Therapy, Ex vivo Model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,126 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Feb 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.
Intracerebral hemorrhage (ICH) is associated with high mortality and long-term disability, and effective treatment options remain limited. Minimally invasive surgical approaches combined with local administration of thrombolytic agents have been investigated to facilitate hematoma evacuation; however, incomplete clot removal remains frequent, particularly in patients with conditions associated with increased hemorrhagic risk.
This observational, cross-sectional study uses an ex vivo model of clinically sized intracerebral hematomas generated from whole blood samples collected from control subjects without hemorrhagic risk and from individuals with predefined hemorrhagic risk profiles, including conditions associated with antithrombotic treatment, inherited bleeding disorders, thrombocytopenia and situations involving reversal or correction of coagulation abnormalities.
Using standardized ex vivo hematoma formation and catheter-based administration of modified Tissue Plasminogen Activator (rtPA), the study will characterize clot structure, composition, and permeability across hemorrhagic risk conditions. The study will then determine personalized dosing regimens of modified rtPA in conditions where thrombolytic activity differs from reference values observed in healthy control samples treated with a standard dose. Finally, the thrombolytic activity of personalized dosing regimens will be evaluated by measuring hematoma weight reduction 9 hours after treatment and compared with predefined efficacy and safety reference boundaries.
The results of this study are intended to improve understanding of the ex vivo thrombolytic performance of modified rtPA across different hemorrhagic risk contexts and to support future translational and clinical research in intracerebral hemorrhage.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biospecimen donors | – | Other: Ex vivo exposure to modified rtPAParticipants will undergo a single whole blood collection (30 mL) during a routine clinical visit. No investigational medicinal product is administered to participants. Collected blood samples will be anonymized and used ex vivo to generate clinically sized intracerebral hematomas, which will subsequently be exposed to rtPA for experimental analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving routine outpatient care who are either without hemorrhagic risk or have predefined hemorrhagic risk profiles, including antithrombotic treatment, inherited bleeding disorders, thrombocytopenia, or conditions requiring reversal or correction of coagulation abnormalities, and who consent to a single blood sample collection.
Key inclusion criteria (7 listed)
- Adult participants (≥ 18 years of age)
- Able and willing to provide written informed consent
- Receiving routine outpatient care
- Either:
- Without identified hemorrhagic risk (control subjects)
Key exclusion criteria (8 listed)
- Age < 18 years
- Inability or unwillingness to provide written informed consent
- Contraindication to venipuncture or blood sampling
- Known human immunodeficiency virus (HIV) infection
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex vivo exposure to modified rtPANo intervention is administered to participants. Modified rtPA is applied exclusively ex vivo to anonymized blood-derived hematoma samples generated after biospecimen collection, for experimental evaluation of thrombolytic activity. | Other | Biospecimen donors |
Primary outcome
Hematoma Lysis Rate
Time frame: 9 hours after ex vivo administration of rtPA
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 19 May 2026.
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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.
Mélanie Daniel, MD principal investigator
University Hospital, Lille
1 site 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 and Hemorrhagic Risk Conditions, run by University Hospital, Lille at 1 site 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 7 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 19 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 1 site 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 Mélanie DANIEL, MD (+33 3 20 44 48 42, melanie.daniel@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma Lysis Rate (time frame: 9 hours after ex vivo administration of rtPA). 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 19 May 2026.