RecruitingNCT06376786

Italian iTTP Registry

Italian iTTP Registry (a Prospective Observational Study)

Sponsor

Fondazione Luigi Villa

Enrollment

132 participants

Start Date

Jun 20, 2024

Study Type

OBSERVATIONAL

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Summary

ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy. A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years.

Eligibility

Min Age: 12 YearsMax Age: 99 Years

Inclusion Criteria3

Patients with an acute iTTP episode (first event or relapse), defined by thrombocytopenia and microangiopathic hemolytic anemia, in the absence of alternative causes, and the presence of severe deficiency of ADAMTS13 activity (\< 10 IU/dL or \<10% of normal value) and anti-ADAMTS13 autoantibodies
Both male and female patients, aged 12 years or older
Patients who have signed the informed consent for the participation to the study