STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA

Summary

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)

Conditions

• TTP - Thrombotic Thrombocytopenic Purpura

Interventions

DIAGNOSTIC_TEST

Factor VIII (FVIII)

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

Von Willebrand factor (VWF) antigen

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

VWF:RCo

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

VWF-propeptide

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

VWF multimers

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

sP-selectin

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

sCD40L

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

F1+2

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

VEGF-A

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

VCAM

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

ICAM

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

IL-1β

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

IL-6

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

PTX3

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

BlyS

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_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

DIAGNOSTIC_TEST

soluble C5b-9

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

C5a

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

NFL

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

GFAP

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_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

DIAGNOSTIC_TEST

Microfluidic Flow Chamber

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

GENETIC

Whole exome sequencing - WES

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

DIAGNOSTIC_TEST

Proteomic Analysis

The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Sponsors & Collaborators

• Istituto Auxologico Italiano

  collaborator OTHER

• Centro Cardiologico Monzino

  collaborator OTHER

• Politecnico di Milano

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2031-01-31

Completion

2032-01-31

Countries

• Italy

Study Locations