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MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

5. Juni 2026 aktualisiert von: 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)

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

TTP – Thrombotisch-thrombozytopenische Purpura

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Diagnose
Zuteilung: Nicht randomisiert
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

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

Teilnehmergruppe / Arm