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NCT Number: NCT05950750

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

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)

Recruiting

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Key information

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of episodes

    Time frame: Through study completion, an average of 4 years

    Median number of episodes will be given

  2. To describe treatment patterns among TTP patients

    Time frame: Through study completion, an average of 4 years

    All treatments received by patients will be expressed as percentages

Secondary outcomes

  1. To describe demographic characteristics of TTP patients

    Time frame: 24 months

    Age, sex, family history, comorbidities will be expressed as percentages

Study contacts

Contact information is provided by the study sponsor or research team.

ilker kurkcu

CONTACT

[email protected]

+905326354515

Sponsors and collaborators

Lead sponsor

Turkish Hematology Association

Other

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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