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MICROVASCULAR DAMAGE IN THROMBOTIC THROMBOCYTOPENIC PURPURA (MITHO)

2026年6月5日更新者：Flora Peyvandi、Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

STUDY OF MICROVASCULAR DAMAGE IN PATIENTS WITH 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)

調査の概要

状態

積極的、募集していない

条件

TTP - 血栓性血小板減少性紫斑病

介入・治療

研究の種類

介入

入学 (推定)

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

イタリア
- Milano
  - Milan、Milano、イタリア、20122
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：診断
割り当て：非ランダム化
介入モデル：並列代入
マスキング：なし（オープンラベル）

アーム数

武器と介入

参加者グループ / アーム	介入・治療
他の：Acute TTP Patients enrolled during acute phase (cohort 1), T0= within 15 days from hospital admission.	診断テスト：Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：BlyS The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice 遺伝的：Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice
他の：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	診断テスト：Factor VIII (FVIII) The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Von Willebrand factor (VWF) antigen The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF:RCo The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF-propeptide The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VWF multimers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：sP-selectin The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：sCD40L The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：F1+2 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VEGF-A The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：VCAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：ICAM The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：IL-1β The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：IL-6 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：PTX3 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Neutrophil elastase and myeloperoxidase (NETs) markers The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：soluble C5b-9 The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：C5a The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：NFL The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：GFAP The study is defined as interventional because it includes assessments that are not part of routine clinical practice 遺伝的：Whole exome sequencing - WES The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：Proteomic Analysis The study is defined as interventional because it includes assessments that are not part of routine clinical practice 診断テスト：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 診断テスト：Microfluidic Flow Chamber The study is defined as interventional because it includes assessments that are not part of routine clinical practice

参加者グループ / アーム