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MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

5 de junio de 2026 actualizado por: Flora Peyvandi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA

The goal of this interventional, non-pharmacological clinical study is to assess microcirculatory dysfunction in patients with thrombotic thrombocytopenic purpura (TTP), both during the acute phase and in remission, compared with the general population.

Microcirculatory damage will be defined as the presence of at least one abnormal instrumental finding among brain magnetic resonance imaging (MRI), optical coherence tomography angiography (OCT-A), and nailfold videocapillaroscopy.

This is a monocentric, national study including two patient cohorts:

Cohort 1: patients enrolled during the acute phase Cohort 2: patients enrolled during remission Participants will be followed for three years with a total of five study visits.

Researchers will not test any drug but will perform detailed clinical, laboratory, and instrumental assessments to evaluate microvascular involvement over time.

Participants will:

Undergo clinical evaluation, including internal medicine and neurological assessments
Provide blood and urine samples for laboratory analyses
Undergo instrumental examinations such as brain MRI, OCT-A, and nailfold videocapillaroscopy
Receive psychological/neuropsychological evaluations
Attend follow-up visits over a 3-year period (at baseline, 3 months [cohort 1 only], 12, 24, and 36 months)

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

TTP - Púrpura trombocitopénica trombótica

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

Fase

No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Italia
- Milano
  - Milan, Milano, Italia, 20122
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

Adulto
Adulto Mayor

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

aged ≥18 years
diagnosis of TTP (either congenital or acquired immune-mediated TTP)
referred at our hospital (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, S.C. Medicina - Emostasi e Trombosi)
providing a signed informed consent

Exclusion Criteria:

Patients who do not possess the above inclusion criteria
Patients who have known contraindications to the instrumental exam included in the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Diagnóstico
Asignación: No aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Otro: Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	Prueba de diagnóstico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genético: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Otro: Remission TTP Patients enrolled during clinical remission (cohort 2), T0= check-up visit performed at more than 3 months from clinical response of the previous episode	Prueba de diagnóstico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genético: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: evaluation of thrombus formation with Total Thrombus formation Analysis System (T-TAS) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Prueba de diagnóstico: Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Grupo de participantes/brazo