跳至主要内容
临床试验/NCT05389007
NCT05389007招募中不适用

German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up

Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2016年7月8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
156
试验地点
1
主要终点
Predictive markers for morbidity and mortality

研究概览

简要总结

Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

详细描述

1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

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

  • Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of
  • Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
  • Written informed consent of the patient.

排除标准

  • Patients who are not able to understand the German or English language.
  • Patients who are permanently unable to communicate and who are not accompanied by a legal representative.

结局指标

主要结局

Predictive markers for morbidity and mortality

时间窗: 3 years

Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry

次要结局

未报告次要终点

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charis v. Auer

Head of Hemostaseology, Principal Investigator

Johannes Gutenberg University Mainz

研究点 (1)

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