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Active, Not Recruiting

NCT Number: NCT07615244

MICROVASCULAR DAMAGE IN 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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

TTP - Thrombotic Thrombocytopenic Purpura Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombophilia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Factor VIII (FVIII)

Diagnostic Test

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

Von Willebrand factor (VWF) antigen

Diagnostic Test

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

VWF:RCo

Diagnostic Test

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

VWF-propeptide

Diagnostic Test

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

VWF multimers

Diagnostic Test

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

sP-selectin

Diagnostic Test

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

sCD40L

Diagnostic Test

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

F1+2

Diagnostic Test

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

VEGF-A

Diagnostic Test

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

VCAM

Diagnostic Test

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

ICAM

Diagnostic Test

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

IL-1β

Diagnostic Test

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

IL-6

Diagnostic Test

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

PTX3

Diagnostic Test

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

BlyS

Diagnostic Test

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

Neutrophil elastase and myeloperoxidase (NETs) markers

Diagnostic Test

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

soluble C5b-9

Diagnostic Test

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

C5a

Diagnostic Test

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

NFL

Diagnostic Test

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

GFAP

Diagnostic Test

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)

Diagnostic Test

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

Microfluidic Flow Chamber

Diagnostic Test

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

Whole exome sequencing - WES

Genetic

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

Proteomic analysis

Diagnostic Test

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

Primary outcomes

  1. Prevalence

    Time frame: From enrollment to the last visit (after 36 months from Time 0)

    Prevalence of microcirculation damage in iTTP patients compared to general population

Secondary outcomes

  1. Cerebral microcirculation lesions

    Time frame: From enrollment to the last visit (after 36 months from Time 0)

    Evaluate cerebral microcirculation lesions (via brain MRI) in both acute and remission phases of TTP to monitor organ damage progression over time

  2. Retinal microcirculation changes

    Time frame: From enrollment to the last visit (after 36 months from Time 0)

    Assess retinal microcirculation changes (using OCT and OCT-A) during acute and remission phases of TTP to track organ damage evolution

  3. Peripheral microcirculation

    Time frame: From enrollment to the last visit (after 36 months from Time 0)

    Analyze peripheral microcirculation (with nailfold videocapillaroscopy) in acute and remission phases to evaluate progression of organ involvement in TTP

  4. Association between cerebral MRI lesions and cognitive or psychological symptoms

    Time frame: From enrollment to the last visit (36 months from Time 0)

    Explore the relationship between cerebral MRI lesions and cognitive or psychological symptoms during TTP remission, assessing symptom progression

  5. Modification of preclinical biomarkers

    Time frame: From enrollment to the last visit (36 months from Time 0)

    Explore the modification of preclinical biomarkers over time at different stage of the disease

  6. Associations between preclinical biomarkers and microcirculatory damage

    Time frame: From enrollment to the last visit (36 months from Time 0)

    Identify associations between preclinical biomarkers and microcirculatory damage in both acute and remission phases of TTP to predict risk and progression

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Centro Cardiologico Monzino
  • Istituto Auxologico Italiano
  • Politecnico di Milano

Registry information

Official study title

STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA

Acronym: MITHO

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
May 29, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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