TTP - Thrombotic Thrombocytopenic PurpuraMITHONCT07615244

MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA

A study testing Factor VIII (FVIII), Von Willebrand factor (VWF) antigen and VWF:RCo in people with TTP - Thrombotic Thrombocytopenic Purpura, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: TTP - Thrombotic Thrombocytopenic Purpura
What is being tested?: Factor VIII (FVIII), Von Willebrand factor (VWF) antigen and VWF:RCo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteItaly
Study dates: 28 Feb 2026to 31 Jan 2032
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Patients who do not possess the above inclusion criteria
Patients who have known contraindications to the instrumental exam included in the study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

Other trials in Italy

About this study

Official title: STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA

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
Being tested: Factor VIII (FVIII), Von Willebrand factor (VWF) antigen, VWF:RCo, VWF-propeptide, VWF multimers
Medical subject headings: Purpura, Thrombotic Thrombocytopenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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) antigenDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
VWF:RCoDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
VWF-propeptideDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
VWF multimersDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
sP-selectinDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
sCD40LDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
F1+2Diagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
VEGF-ADiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
VCAMDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
ICAMDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
IL-1βDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
IL-6Diagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
PTX3Diagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
BlySDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Neutrophil elastase and myeloperoxidase (NETs) markersDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
soluble C5b-9Diagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
C5aDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
NFLDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
GFAPDiagnostic 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 ChamberDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Whole exome sequencing - WESGenetic
The study is defined as interventional because it includes assessments that are not part of routine clinical practice
Proteomic AnalysisDiagnostic test
The study is defined as interventional because it includes assessments that are not part of routine clinical practice

Study groups in NCT07615244
Study group	Role	What they receive
Acute TTP	Other	Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission. Receives: Diagnostic Test: Factor VIII (FVIII); Diagnostic Test: Von Willebrand factor (VWF) antigen; Diagnostic Test: VWF:RCo; Diagnostic Test: VWF-propeptide; Diagnostic Test: VWF multimers; Diagnostic Test: sP-selectin; Diagnostic Test: sCD40L; Diagnostic Test: F1+2; Diagnostic Test: VEGF-A; Diagnostic Test: VCAM; Diagnostic Test: ICAM; Diagnostic Test: IL-1β; Diagnostic Test: IL-6; Diagnostic Test: PTX3; Diagnostic Test: BlyS; Diagnostic Test: Neutrophil elastase and myeloperoxidase (NETs) markers; Diagnostic Test: soluble C5b-9; Diagnostic Test: C5a; Diagnostic Test: NFL; Diagnostic Test: GFAP; Genetic: Whole exome sequencing - WES; Diagnostic Test: Proteomic Analysis
Remission TTP	Other	Patients enrolled during clinical remission (cohort 2), T0= check-up visit performed at more than 3 months from clinical response of the previous episode Receives: Diagnostic Test: Factor VIII (FVIII); Diagnostic Test: Von Willebrand factor (VWF) antigen; Diagnostic Test: VWF:RCo; Diagnostic Test: VWF-propeptide; Diagnostic Test: VWF multimers; Diagnostic Test: sP-selectin; Diagnostic Test: sCD40L; Diagnostic Test: F1+2; Diagnostic Test: VEGF-A; Diagnostic Test: VCAM; Diagnostic Test: ICAM; Diagnostic Test: IL-1β; Diagnostic Test: IL-6; Diagnostic Test: PTX3; Diagnostic Test: Neutrophil elastase and myeloperoxidase (NETs) markers; Diagnostic Test: soluble C5b-9; Diagnostic Test: C5a; Diagnostic Test: NFL; Diagnostic Test: GFAP; Diagnostic Test: evaluation of thrombus formation with Total Thrombus formation Analysis System (T-TAS); Diagnostic Test: Microfluidic Flow Chamber; Genetic: Whole exome sequencing - WES; Diagnostic Test: Proteomic Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Cerebral microcirculation lesions
Evaluate cerebral microcirculation lesions (via brain MRI) in both acute and remission phases of TTP to monitor organ damage progression over time
Measured: From enrollment to the last visit (after 36 months from Time 0)
Retinal microcirculation changes
Assess retinal microcirculation changes (using OCT and OCT-A) during acute and remission phases of TTP to track organ damage evolution
Measured: From enrollment to the last visit (after 36 months from Time 0)
Peripheral microcirculation
Analyze peripheral microcirculation (with nailfold videocapillaroscopy) in acute and remission phases to evaluate progression of organ involvement in TTP
Measured: From enrollment to the last visit (after 36 months from Time 0)
Association between cerebral MRI lesions and cognitive or psychological symptoms
Explore the relationship between cerebral MRI lesions and cognitive or psychological symptoms during TTP remission, assessing symptom progression
Measured: From enrollment to the last visit (36 months from Time 0)
Modification of preclinical biomarkers
Explore the modification of preclinical biomarkers over time at different stage of the disease
Measured: From enrollment to the last visit (36 months from Time 0)
Associations between preclinical biomarkers and microcirculatory damage
Identify associations between preclinical biomarkers and microcirculatory damage in both acute and remission phases of TTP to predict risk and progression
Measured: From enrollment to the last visit (36 months from Time 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202631 Jan 2032

First posted29 May 2026
Study start28 Feb 2026
Primary completion31 Jan 2031 (estimated)
Study completion31 Jan 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TTP - Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07615244
Sponsor's protocol ID: IRCCSMaggioreH
Acronym: MITHO
Status last verified: Jun 2026
First submitted: 22 May 2026
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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