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STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

22 maggio 2026 aggiornato da: Flora Peyvandi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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)

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

TTP - Porpora Trombotica Trombocitopenica

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

Inclusion Criteria:

aged ≥18 years
with a confirmed diagnosis of TTP (either congenital or acquired immune-mediated TTP)
referred at our hospital (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) in acute phase of a first or recurrent episode (cohort 1) or referred at our outpatient clinic (S.C. Medicina - Emostasi e Trombosi) during clinical remission at more than 3 months from the clinical response of the previous episode (cohort 2). In any case, patient enrolment will always take place in the S.C. Medicina - Emostasi e Trombosi
providing a signed informed consent

Exclusion Criteria:

- Patients who do not possess the above inclusion criteria or have known contraindications to the instrumental exam included in the study (MRI).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Diagnostico
Assegnazione: Non randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Altro: Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	Test diagnostico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test 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 Test diagnostico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genetico: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Altro: 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	Test diagnostico: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test 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 Test diagnostico: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genetico: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test diagnostico: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice Test 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 Test diagnostico: Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Gruppo di partecipanti / Arm