NCT04810143已完成不适用
Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling (VAMS) and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Accuracy of +/-10%
研究概览
简要总结
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.
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
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age
- •Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
- •Aim 2: outpatient
- •Currently taking tacrolimus
排除标准
- •Non-English-speaking patients
- •Unable to access overnight delivery services (Aim 2 only)
结局指标
主要结局
Accuracy of +/-10%
时间窗: 18-24 months from start of enrollment
A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.
次要结局
未报告次要终点
研究者
研究点 (2)
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