Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- One year mortality
研究概览
简要总结
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.
详细描述
Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age
- •Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.
排除标准
- •Subject is less than 18 years of age.
- •Known prisoners of the state.
- •Subject is pregnant.
- •Non- English speaking patients will be excluded from the blood sub-study
结局指标
主要结局
One year mortality
时间窗: One year
Mortality will be assessed yearly.
次要结局
- Cytokine Analysis(Pre-implant, within 24 hours of implant, and 7 days post-implant)
- Hospital readmissions(Will be assessed yearly until death or explant)
- Inflammatory cell subtype(Pre-implant, within 24 hours of implant, and 7 days post-implant)
研究者
Renzo Loyaga Rendon
Renzo Loyaga Rendon MD
Spectrum Health Hospitals