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临床试验/NCT02324517
NCT02324517Unknown不适用

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Thrombin Generation Parameters pre and post therapy / spiking assays

研究概览

简要总结

Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.

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
6 Months 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Validated coagulation disorder

排除标准

  • Not consenting to participate
  • Multiple coagulopathies and comorbidities

结局指标

主要结局

Thrombin Generation Parameters pre and post therapy / spiking assays

时间窗: 1 year from enrollment

Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder.

次要结局

未报告次要终点

研究者

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

Prof. Gila Kenet MD

Director- Thrombosis Unit

Sheba Medical Center

研究点 (1)

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