Evaluation of a Pediatric Reference Interval Using QPLUS System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Reference range interval for measurement of clot time (CT) parameter
研究概览
简要总结
Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.
详细描述
Single center observational study of the pediatric patient population (< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for procedure requiring anesthesia
- •Access to blood sampling
- •Consented
排除标准
- •>18yrs of age
- •pre-term babies
- •patients with know hematological disorders
- •Difficult to obtain blood sampling
- •Has received a blood product transfusion within the last 24hrs.
- •Legal guardian unwilling to consent
结局指标
主要结局
Reference range interval for measurement of clot time (CT) parameter
时间窗: Baseline, after access placement before any procedures
Reference range interval determined in this study will serve as the reference for CT results in this particular population
Reference range interval for measurement of clot stiffness (CS) parameter
时间窗: Baseline, after access placement before any procedures
Reference range interval determined in this study will serve as the reference for CS results in this particular population
Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter
时间窗: Baseline, after access placement before any procedures
Reference range interval determined in this study will serve as the reference for PCS results in this particular population
Reference range interval for measurement of clot time (CTH) parameter
时间窗: Baseline, after access placement before any procedures
Reference range interval determined in this study will serve as the reference for CTH results in this particular population
Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter
时间窗: Baseline, after access placement before any procedures
Reference range interval determined in this study will serve as the reference for FCS results in this particular population
次要结局
未报告次要终点