Ex Vivo Hematoma Thrombolysis With Modified rtPA for ICH
Official title: Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator to Improve Parenchymal Clearance in Intracerebral Hemorrhage
Run by University Hospital, Lille · NCT07411079 · Data updated 2026-11-12
This study tests whether a modified tissue plasminogen activator can help dissolve blood clots outside the body using blood samples from people with and without bleeding risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1126 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | March 2029 |
| Study ends | March 2029 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07411079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing routine outpatient care, either without hemorrhagic risk or with predefined hemorrhagic risk profiles (antithrombotic treatment, inherited bleeding disorders, thrombocytopenia, or coagulation abnormalities requiring reversal).
✕Probably not a fit
Participants will not receive any direct medical benefit from this ex vivo study, and results are intended to inform future research.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, cross-sectional study using ex vivo models of intracerebral hematomas created from whole blood. It compares clot dissolution after catheter-based delivery of a modified rtPA in samples from adults with and without hemorrhagic risk factors, including antithrombotic use and inherited bleeding disorders. The goal is to understand how such risk factors may affect clot breakdown in a controlled, laboratory setting. No in vivo testing in patients is performed; the work is conducted on ex vivo hematoma models to inform potential therapeutic approaches. The investigation is led by University Hospital, Lille, with sites at CHU de Lille, and involves a single additional blood collection per participant.
Why it matters
Potential benefit: If successful, this approach could inform safer, more effective thrombolysis strategies for intracerebral hemorrhage in patients with bleeding risk factors.
How similar studies have gone: Prior research has explored catheter-based thrombolysis for hematoma evacuation, but this ex vivo approach with modified rtPA and varied hemorrhagic risk profiles is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where it's running
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CHU de Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Mélanie Daniel, MD — University Hospital, Lille
- Study coordinator: Mélanie DANIEL, MD
- Email: melanie.daniel@chu-lille.fr
- Phone: +33 3 20 44 48 42
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.