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

22. května 2026 aktualizováno: 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)

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

TTP - Trombotická trombocytopenická purpura

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

Fáze

Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Itálie
- Milano
  - Milan, Milano, Itálie, 20122
    - Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Diagnostický
Přidělení: Nerandomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Jiný: Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	Diagnostický test: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genetický: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Jiný: 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	Diagnostický test: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice Genetický: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice Diagnostický test: 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 Diagnostický test: Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Skupina účastníků / Arm