NCT07615244

Brief 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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
67mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Jan 2032

Study Start

First participant enrolled

February 28, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2032

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

4.9 years

First QC Date

May 22, 2026

Last Update Submit

June 5, 2026

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • Prevalence

    Prevalence of microcirculation damage in iTTP patients compared to general population

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

Secondary Outcomes (6)

  • Cerebral microcirculation lesions

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

  • Retinal microcirculation changes

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

  • Peripheral microcirculation

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

  • Association between cerebral MRI lesions and cognitive or psychological symptoms

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

  • Modification of preclinical biomarkers

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

  • +1 more secondary outcomes

Study Arms (2)

Acute TTP

OTHER

Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.

Diagnostic Test: Factor VIII (FVIII)Diagnostic Test: Von Willebrand factor (VWF) antigenDiagnostic Test: VWF:RCoDiagnostic Test: VWF-propeptideDiagnostic Test: VWF multimersDiagnostic Test: sP-selectinDiagnostic Test: sCD40LDiagnostic Test: F1+2Diagnostic Test: VEGF-ADiagnostic Test: VCAMDiagnostic Test: ICAMDiagnostic Test: IL-1βDiagnostic Test: IL-6Diagnostic Test: PTX3Diagnostic Test: BlySDiagnostic Test: Neutrophil elastase and myeloperoxidase (NETs) markersDiagnostic Test: soluble C5b-9Diagnostic Test: C5aDiagnostic Test: NFLDiagnostic Test: GFAPGenetic: Whole exome sequencing - WESDiagnostic 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

Diagnostic Test: Factor VIII (FVIII)Diagnostic Test: Von Willebrand factor (VWF) antigenDiagnostic Test: VWF:RCoDiagnostic Test: VWF-propeptideDiagnostic Test: VWF multimersDiagnostic Test: sP-selectinDiagnostic Test: sCD40LDiagnostic Test: F1+2Diagnostic Test: VEGF-ADiagnostic Test: VCAMDiagnostic Test: ICAMDiagnostic Test: IL-1βDiagnostic Test: IL-6Diagnostic Test: PTX3Diagnostic Test: Neutrophil elastase and myeloperoxidase (NETs) markersDiagnostic Test: soluble C5b-9Diagnostic Test: C5aDiagnostic Test: NFLDiagnostic Test: GFAPDiagnostic Test: evaluation of thrombus formation with Total Thrombus formation Analysis System (T-TAS)Diagnostic Test: Microfluidic Flow ChamberGenetic: Whole exome sequencing - WESDiagnostic Test: Proteomic Analysis

Interventions

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

Acute TTPRemission TTP
VWF multimersDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
VCAMDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
ICAMDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
IL-1βDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
IL-6DIAGNOSTIC_TEST

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

Acute TTPRemission TTP
PTX3DIAGNOSTIC_TEST

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

Acute TTPRemission TTP
Factor VIII (FVIII)DIAGNOSTIC_TEST

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

Acute TTPRemission TTP
Von Willebrand factor (VWF) antigenDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
VWF:RCoDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
VWF-propeptideDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
sCD40LDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
F1+2DIAGNOSTIC_TEST

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

Acute TTPRemission TTP
VEGF-ADIAGNOSTIC_TEST

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

Acute TTPRemission TTP
BlySDIAGNOSTIC_TEST

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

Acute TTP
soluble C5b-9DIAGNOSTIC_TEST

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

Acute TTPRemission TTP
C5aDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
NFLDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
GFAPDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
Microfluidic Flow ChamberDIAGNOSTIC_TEST

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

Remission TTP
Whole exome sequencing - WESGENETIC

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

Acute TTPRemission TTP
sP-selectinDIAGNOSTIC_TEST

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

Acute TTPRemission TTP
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

Remission TTP
Proteomic AnalysisDIAGNOSTIC_TEST

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

Acute TTPRemission TTP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have known contraindications to the instrumental exam included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

Exome Sequencing

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Whole Genome SequencingSequence Analysis, DNASequence AnalysisGenetic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of S.C. Medicina Emostasi e Trombosi

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

January 31, 2032

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations

IT(1)