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

22. maj 2026 opdateret af: 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)

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

TTP - Trombotisk trombocytopenisk purpura

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Diagnostisk
Tildeling: Ikke-randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

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

Deltagergruppe / Arm