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STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
79
Start Date
2026-02-28
Completion Date
2032-01-31
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
Factor VIII (FVIII)
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VWF:RCo
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VWF-propeptide
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VWF multimers
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sP-selectin
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sCD40L
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F1+2
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VEGF-A
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VCAM
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ICAM
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IL-1β
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IL-6
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PTX3
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BlyS
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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
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GFAP
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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
Locations (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy