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

22 maja 2026 zaktualizowane przez: 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)

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

TTP - zakrzepowa plamica małopłytkowa

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Diagnostyczny
Przydział: Nielosowe
Model interwencyjny: Przydział równoległy
Maskowanie: Brak (otwarta etykieta)

Liczba ramion

Broń i interwencje

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

Grupa uczestników / Arm