Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Обзор

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)

Подробное описание

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)

Первичные конечные точки

• Number of episodes [Срок оценки: Through study completion, an average of 4 years]
• To describe treatment patterns among TTP patients [Срок оценки: Through study completion, an average of 4 years]

Вторичные конечные точки (1)

• To describe demographic characteristics of TTP patients [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Diagnosed as aTTP after 01.01.2015
• Patients with ADAMS13<10%
• Thrombocytopenia (<100.000)
• Coombs (-)
• Microangiopathic hemolytic amenia
• 18 years and older

Критерии исключения

\- Patient who does not sign informed consent form

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Baskent Universtiy Faculty of Medicine — Ankara

Публикации

• Karakus S, Bakanay SM, Kalayoglu Besisik S, Eskazan AE, Ayyildiz O, Gurkan E, Salim O, Karakus V, Guler N, Keklik M, Ozcebe OI, Ozkalemkas F, Ozkocaman V, Yilmaz U, Dadin S, Ucar MA, Sonmez M, Karakus A, Atas U, Koc LZ, Gunduz E, Kabukcu Hacioglu S, Unver Koluman B, Ozet G, Guney T, Fidan K, Karaagac Akyol T, Kikili CI, Demirkan F, Yavasoglu I, Dagtas S, Kestane M, Uskudar Teke H, Kocak Toprak S, PMID 40699136

Идентификаторы

NCT: NCT05950750 · eTTP-THD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗