Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05950750

Enrollment

960

Registered

2023-07-18

Start date

2022-12-21

Completion date

2026-12-21

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Keywords

TTP, THD

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of episodes	Through study completion, an average of 4 years	Median number of episodes will be given
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

Secondary

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

Countries

Turkey (Türkiye)

Contacts

Primary Contactilker kurkcu

ilker.kurkcu@sentez-cro.com+905326354515

Outcome results