French Adult Primary Immune Thrombocytopenia

Study Overview
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Brief Summary
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Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.

Official Title
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French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Other: Medical information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incident case of immune thrombocytopenia or control patient Exclusion Criteria: Patient not registered in the database between 2009 and 2012

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Data to be collected are : - Medical information on Immune Thrombocytopenia treatment | Other: Medical information<br>* The information collected are about : Introduction or non-introduction of treatment Cumulative dose of treatment Drug dispensation and withdrawal Hospitalization reason Safety information Demographic data (date of death)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposition or non exposition to available immune thrombocytopenia persistent | Data will be extracted until the end of study | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality as assessed date of death collected in the database | Data will be extracted every year of the study until the end of study | Each year until 10 years | 
| Number of hospitalization for bleeding in the database | Number of hospitalization for bleeding will be extract from database every year | Each year until 10 years | 
| Safety of treatment for infections | Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year | Each year until 10 years | 
| Safety of treatment for cardio-vascular events | Number of hospitalization for cardio-vascular events will be extract from database every year | Each year until 10 years | 
| Safety of treatment for thrombo-embolic events | Number of hospitalization for thrombo-embolic events will be extract from database every year | Each year until 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease epidemiology, Risk assessment, Drug utilisation study, Effectiveness evaluation