Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

perjantai 5. kesäkuuta 2026 päivittänyt: 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)

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

TTP - tromboottinen trombosytopeeninen purppura

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

Vaihe

Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

Aikuinen
Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Ensisijainen käyttötarkoitus: Diagnostiikka
Jako: Ei satunnaistettu
Inventiomalli: Rinnakkaistehtävä
Naamiointi: Ei mitään (avoin tarra)

Aseiden lukumäärä

Aseet ja interventiot

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

Osallistujaryhmä / Arm