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Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator for Intracerebral Hemorrhage

Recruitingn/aAges 18 Years - 65 YearsAllUniversity Hospital, Lille
NCT07411079 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 standardiz

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📋 Eligibility rules (as published)
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)
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What it tests

  • Ex vivo exposure to modified rtPA
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Where

1 site
CHU de Lille
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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