MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA

Condition(s) studied

Investigational drug(s) / intervention(s)

Factor VIII (FVIII): The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Von Willebrand factor (VWF) antigen: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

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

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

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

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

sCD40L: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

F1+2: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

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

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

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

IL-1β: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

IL-6: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

PTX3: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

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

Neutrophil elastase and myeloperoxidase (NETs) markers: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

soluble C5b-9: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

C5a: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

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

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

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

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

Whole exome sequencing - WES: The study is defined as interventional because it includes assessments that are not part of routine clinical practice

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

Study 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)

Eligibility

Primary outcome measure(s)

• Prevalence — From enrollment to the last visit (after 36 months from Time 0)
  Prevalence of microcirculation damage in iTTP patients compared to general population

Trial sites (1)

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy

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