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

Recruiting now

Conditions studied: Intracerebral Hemorrhage, Hemorrhagic Risk Conditions, Bleeding Disorders

In brief

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.

Key facts

Study ID

NCT07411079

Run by

University Hospital, Lille

People needed

1126

Starts

2026-03-02

Expected to finish

2029-03-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• CHU de Lille — Lille, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.