Clinical Evaluation of the i-STAT ACTpro Cartridge Using Venous and Arterial Whole Blood Specimens on the i-STAT 1 Analyzer in an Adult Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Compare ACT test results obtained from two different diagnostic devices.
研究概览
简要总结
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.
详细描述
The purpose of this study is to conduct a clinical evaluation of the investigational i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device for measuring Activated Clotting Time (ACT) on venous and arterial whole blood specimens from adult participants.
The study will be conducted using whole blood specimens from participants undergoing Dialysis, Extracorporeal Life Support (ECLS)/ Extracorporeal Membrane Oxygenation (ECMO), and procedures in Electrophysiology Laboratories (EP Labs), Cardiac Catheterization Laboratories (Cath Labs), Interventional Radiology (IR) Units, and Cardiovascular Operating Rooms (CVOR).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is prescribed unfractionated heparin (UFH) peri-procedurally in order to reduce the risk of blood clots.
- •- Subject for which only the baseline specimen (prior to UFH administration) is collected, subject is admitted for a medical procedure that would or could typically necessitate the use of UFH to reduce the risk of blood clots.
排除标准
- •Prior enrollment in the study.
研究组 & 干预措施
Activated Clotting Time (ACT) in venous and arterial whole blood specimens.
Arterial and/or venous specimens from enrolled subjects will be tested in duplicate on the i-STAT 1 analyzer with the i-STAT ACTpro cartridge, and on the comparator device.
干预措施: Blood draw (Diagnostic Test)
结局指标
主要结局
Compare ACT test results obtained from two different diagnostic devices.
时间窗: Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.
Compare ACT test results obtained from the ACTpro cartridge using the i-STAT 1 analyzer with the ACT test result obtained from a comparator device using whole blood specimens.
次要结局
- Precision assessment.(Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.)