Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Reference range intervals for measurement of Clot Time (CT) parameter
研究概览
简要总结
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
详细描述
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
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
- 否
入选标准
- •Subject is <18 years of age
- •Corrected gestational age ≥ 37weeks
- •Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤
- •Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.
排除标准
- •Subject is hospitalized in the Pediatric Intensive Care Unit
- •Subject requires Extracorporeal Membrane Oxygenation (ECMO)
- •Subject has had an infection within 7 days of the scheduled procedure
- •Subject has an active coagulation disorder (bleeding or thrombosis)
- •For subjects that have a hemoglobin measurement within 24 hours of the scheduled procedure, hemoglobin is <8g/dL or >16g/dL
- •Subject has a baseline oxygen saturation <92%
研究组 & 干预措施
Pediatric patients
干预措施: Quantra System (Diagnostic Test)
结局指标
主要结局
Reference range intervals for measurement of Clot Time (CT) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals for CT in pediatric patients
Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter
时间窗: Baseline, determined from a single blood draw.
Reference range intervals for CTH in pediatric patients
Reference range intervals for measurement of Clot Stiffness (CS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals for CS in pediatric patients
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals for FCS in pediatric patients
Reference range intervals for measurement of Platelet Contribution (PCS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals for PCS in pediatric patients
次要结局
未报告次要终点