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.
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Age at onset
Timeframe: 3 years
Sex
Timeframe: 3 years
Birth Country/Region
Timeframe: 3 years
Race
Timeframe: 3 years
Blood group
Timeframe: 3 years
BMI
Timeframe: 3 years
Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression.
Timeframe: 3 years
Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs
Timeframe: 3 years
Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms
Timeframe: 3 years
Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin
Timeframe: 3 years
Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin
Timeframe: 3 years
Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin
Timeframe: 3 years
Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin
Timeframe: 3 years
Cardiac troponin
Timeframe: 3 years
ADAMTS13 activity
Timeframe: 6 years
Anti-ADAMTS13 antibodies
Timeframe: 6 years
Number of daily therapeutic plasma exchange procedures
Timeframe: 3 years
Proportion of acute iTTP patients treated with rituximab
Timeframe: 6 years
Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab
Timeframe: 6 years
Proportion of iTTP patients treated with caplacizumab
Timeframe: 3 years
Incidence, type and severity of TTP-related drugs adverse events
Timeframe: 6 years
Proportion of iTTP patients achieving clinical remission
Timeframe: 6 years
Proportion of iTTP patients refractory to acute iTTP treatment
Timeframe: 6 years
Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications
Timeframe: 6 years
Proportion of iTTP patients experiencing clinical exacerbation
Timeframe: 6 years
Proportion of iTTP patients achieving ADAMTS13 remission
Timeframe: 6 years
Time to clinical response
Timeframe: 6 years
Time to clinical remission
Timeframe: 6 years
Time to ADAMTS13 remission
Timeframe: 6 years
Proportion of iTTP patients with a clinical relapse
Timeframe: 6 years
Proportion of iTTP patients with an ADAMTS13 relapse
Timeframe: 6 years
Time to clinical relapse
Timeframe: 6 years
Time to ADAMTS13 relapse
Timeframe: 6 years
Incidence, type and severity of pregnancy complications in iTTP pregnant women
Timeframe: 6 years