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临床试验/NCT02095821
NCT02095821终止不适用

Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Thrombin clotting time

研究概览

简要总结

Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.

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

  • plasma exchange therapy due to humoral rejection after kidney transplantation

排除标准

  • hereditary coagulopathy
  • chronic liver disease (Child C)
  • therapeutic anticoagulation
  • malnutrition (BMI<17.5)

结局指标

主要结局

Thrombin clotting time

时间窗: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)

Daily measurement after initiation of plasma exchange therapy until treatment course is finished

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julius Schmidt

MD

Hannover Medical School

研究点 (1)

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