Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
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
- 否
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
Prof. Gila Kenet MD
Director- Thrombosis Unit
Sheba Medical Center
