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

Официальное название

Ex Vivo Reproduction of Minimally Invasive Surgery With Hematoma Lysis Using Modified Tissue Plasminogen Activator to Improve Parenchymal Clearance in Intracerebral Hemorrhage

Обзор

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.

Вмешательства

• Другое Ex vivo exposure to modified rtPA
  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.

Первичные конечные точки

• Hematoma Lysis Rate [Срок оценки: 9 hours after ex vivo administration of rtPA]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07411079 · 2025_0168 · 2025-A02187-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗