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

NCT07411079 | Not Yet Recruiting

• 2 other identifiers: 2025_01682025-A02187-42
• Study Type: observational
• Target: 1,126
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Intracerebral Hemorrhage; Hemorrhagic Risk Conditions; Bleeding Disorders

Keywords

Intracranial Hemorrhages; Hematoma Lysis; Modified Tissue Plasminogen Activator; Bleeding Disorders; Antithrombotic Therapy; Ex vivo Model

Outcome Measures

Primary Outcomes (1)

• Hematoma Lysis Rate

  9 hours after ex vivo administration of rtPA

Study Arms (1)

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.

Other: Ex vivo exposure to modified rtPA

Interventions

Ex vivo exposure to modified rtPA OTHER

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.

Biospecimen donors

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples (30 ml) collected once from each participant during a routine clinical visit. Samples will be anonymized and used to generate clinically sized intracerebral hematomas ex vivo for experimental analysis.

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemostatic Disorders; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mélanie Daniel, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie DANIEL, MD

CONTACT

+33 3 20 44 48 42; melanie.daniel@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02