protocolSection identificationModule nctId: NCT06376786, orgStudyIdInfo id: ItaliTTP, briefTitle: Italian iTTP Registry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2030-05-31, completionDateStruct date: 2030-05-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Fondazione Luigi Villa, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: TTP - Thrombotic Thrombocytopenic Purpura, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Age at onset, primaryOutcomes measure: Sex, primaryOutcomes measure: Birth Country/Region, primaryOutcomes measure: Race, primaryOutcomes measure: Blood group, primaryOutcomes measure: BMI, primaryOutcomes measure: Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression., primaryOutcomes measure: Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs, primaryOutcomes measure: Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms, primaryOutcomes measure: Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Cardiac troponin, primaryOutcomes measure: ADAMTS13 activity, primaryOutcomes measure: Anti-ADAMTS13 antibodies, primaryOutcomes measure: Number of daily therapeutic plasma exchange procedures, primaryOutcomes measure: Proportion of acute iTTP patients treated with rituximab, primaryOutcomes measure: Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab, primaryOutcomes measure: Proportion of iTTP patients treated with caplacizumab, primaryOutcomes measure: Incidence, type and severity of TTP-related drugs adverse events, primaryOutcomes measure: Proportion of iTTP patients achieving clinical remission, primaryOutcomes measure: Proportion of iTTP patients refractory to acute iTTP treatment, primaryOutcomes measure: Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications, primaryOutcomes measure: Proportion of iTTP patients experiencing clinical exacerbation, primaryOutcomes measure: Proportion of iTTP patients achieving ADAMTS13 remission, primaryOutcomes measure: Time to clinical response, primaryOutcomes measure: Time to clinical remission, primaryOutcomes measure: Time to ADAMTS13 remission, primaryOutcomes measure: Proportion of iTTP patients with a clinical relapse, primaryOutcomes measure: Proportion of iTTP patients with an ADAMTS13 relapse, primaryOutcomes measure: Time to clinical relapse, primaryOutcomes measure: Time to ADAMTS13 relapse, primaryOutcomes measure: Incidence, type and severity of pregnancy complications in iTTP pregnant women, secondaryOutcomes measure: iTTP incidence in Italy, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False