Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Study Overview
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Brief Summary
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21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Detailed Description
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Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected. 21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Official Title
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Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Conditions
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TTP - Thrombotic Thrombocytopenic Purpura

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as aTTP after 01.01.2015 Patients with ADAMS13<10% Thrombocytopenia (<100.000) Coombs (-) Microangiopathic hemolytic amenia 18 years and older Exclusion Criteria: - Patient who does not sign informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Patients<br>Non interventional observational | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes | Median number of episodes will be given | Through study completion, an average of 4 years | 
| To describe treatment patterns among TTP patients | All treatments received by patients will be expressed as percentages | Through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe demographic characteristics of TTP patients | Age, sex, family history, comorbidities will be expressed as percentages | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTP, THD