Point of Care Testing to Improve Monitoring of LVAD Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Interclass correlation between PT/INR and LDH measurements
研究概览
简要总结
The purpose of this study is to develop and validate the accuracy of a low-cost "point-of-care" test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-POCT utilizing low-cost (printed) cassettes and detector will produce an inexpensive and convenient option for daily self-monitoring of PT/INR and LDH over existing methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Subject has signed Informed Consent Form (ICF)
- •For LVAD patient cohort, they are on LVAD support from 2 weeks to 10 years.
排除标准
- •Patients with dementia, altered mental status, any psychiatric condition or mental disability that would prohibit the understanding or rendering of informed consent are not eligible
- •Prisoners
结局指标
主要结局
Interclass correlation between PT/INR and LDH measurements
时间窗: 1 study day
The primary outcome is acceptable inter-rater agreement between our measure and the clinical gold standards for both PT/INR and LDH. This will be defined as an interclass correlation of \> 0.8 with a CI lower bound of 0.1 based on the sample size of this study.
次要结局
未报告次要终点