Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator for Intracerebral Hemorrhage (MIMICK-TIPITCH)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Bleeding Disorders; Intracerebral Hemorrhage; Hemorrhagic Risk Conditions

Treatments: Other: Ex vivo exposure to modified rtPA

Study type: Observational

Funder types: Other

Identifiers

NCT07411079

2025-A02187-42 (Other Identifier)

2025_0168

Details and patient eligibility

About

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.

Enrollment: 1,126 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

1,126 participants in 1 patient group

Biospecimen donors

Description:

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.

Treatment:

Other: Ex vivo exposure to modified rtPA