Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders
研究概览
简要总结
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.
详细描述
This is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at UTHealth Houston. The ROTEG is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. This device will not be used as a diagnostic or procedure tool. No recommendations regarding interpretation of the results or implications for future treatment will be provided.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 98 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent
排除标准
- •poor venous access
结局指标
主要结局
Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders
时间窗: 24 hours
Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function
次要结局
未报告次要终点
研究者
Miguel Escobar
Professor - UTHealth McGovern Medical School
The University of Texas Health Science Center, Houston