Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Recruiting

• Conditions: TTP - Thrombotic Thrombocytopenic Purpura

• Registration Number: NCT05950750
• Lead Sponsor: Turkish Hematology Association

Brief Summary

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

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)

Study Timeline

• Study Start: 2022-12-21
• Study First Submitted: 2023-01-31
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-15
• Last Update Submitted: 2023-07-15
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-12-21
• Study Completion: 2026-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 960

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe treatment patterns among TTP patients	Through study completion, an average of 4 years	All treatments received by patients will be expressed as percentages
Number of episodes	Through study completion, an average of 4 years	Median number of episodes will be given

Secondary Outcome Measures

Name	Time	Method
To describe demographic characteristics of TTP patients	24 months	Age, sex, family history, comorbidities will be expressed as percentages

Trial Locations

Locations (1)

Baskent Universtiy Faculty of Medicine; 🇹🇷 Ankara, Turkey