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临床试验/NCT05950750
NCT05950750招募中不适用

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Turkish Hematology Association1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2022年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
960
试验地点
1
主要终点
To describe treatment patterns among TTP patients

研究概览

简要总结

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)

详细描述

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patient who does not sign informed consent form

结局指标

主要结局

To describe treatment patterns among TTP patients

时间窗: Through study completion, an average of 4 years

All treatments received by patients will be expressed as percentages

Number of episodes

时间窗: Through study completion, an average of 4 years

Median number of episodes will be given

次要结局

  • To describe demographic characteristics of TTP patients(24 months)

研究者

发起方
Turkish Hematology Association
申办方类型
Other
责任方
Sponsor

研究点 (1)

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