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MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

5 de junho de 2026 atualizado 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)

Visão geral do estudo

Status

Ativo, não recrutando

Condições

PTT - Púrpura Trombocitopênica Trombótica

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Diagnóstico
Alocação: Não randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Outro: Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	Teste de diagnostico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: 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 Teste de diagnostico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Outro: 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	Teste de diagnostico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: 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 Teste de diagnostico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice Teste de diagnostico: 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 Teste de diagnostico: Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Grupo de Participantes / Braço