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STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

2026년 5월 22일 업데이트: Flora Peyvandi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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)

연구 개요

상태

모집하지 않고 적극적으로

정황

TTP - 혈전성 혈소판감소성 자반병

개입 / 치료

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

aged ≥18 years
with a confirmed diagnosis of TTP (either congenital or acquired immune-mediated TTP)
referred at our hospital (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) in acute phase of a first or recurrent episode (cohort 1) or referred at our outpatient clinic (S.C. Medicina - Emostasi e Trombosi) during clinical remission at more than 3 months from the clinical response of the previous episode (cohort 2). In any case, patient enrolment will always take place in the S.C. Medicina - Emostasi e Trombosi
providing a signed informed consent

Exclusion Criteria:

- Patients who do not possess the above inclusion criteria or have known contraindications to the instrumental exam included in the study (MRI).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 특수 증상
할당: 무작위화되지 않음
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
다른: Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	진단 검사: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice 유전적: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
다른: Remission TTP Patients enrolled during clinical remission (cohort 2), T0= check-up visit performed at more than 3 months from clinical response of the previous episode	진단 검사: Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice 유전적: Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice 진단 검사: 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 진단 검사: Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

참가자 그룹 / 팔