ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- ABL90 FLEX PLUS Clinical Precision
研究概览
简要总结
Conducting the ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood is to validate performance claims for precision of the ABL90 FLEX PLUS ctBil and FHbF parameters in neonatal whole blood while being influenced by testing environment that is representative of intended use environment, site variability, intended use testing environment and operator variability in a Point-of-Care (POC) setting.
The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS.
The study is being conducted in Denmark and in total, a minimum of 54 subjects are to be enrolled to provide successful measurement values from 3 different sites.
详细描述
The conduct of the clinical study is to determine the repeatability of ctBil and FHbF parameters in neonatal whole blood using contrived fetal cord blood from umbilical cord/placenta measured by the intended users in syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.
The primary endpoint is the Repeatability (SD) for each parameter, parameter level and measuring mode, pooled across sites.
Participating sites are maternity wards or similar site conducting planned cesarean sections. Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation will be enrolled in the clinical study. When the subject has signed ICF, the site will collect cord blood from umbilical cord/placenta and when relevant prepare contrived samples by having access to adult type 0 Rh neg whole blood for diluting HbF in cord blood.
Three POC users, such as a nurse, a physician, or a therapist that care for the woman in the maternity ward will perform all measurements and they shall contribute evenly to the total number of samples measured. Replicate measurements shall be performed by the same user.
6-10 mL of cord blood is collected in a blood collection syringe from each umbilical cord/placenta, contrived, and the sample is aliquoted into 5 safePICO aspirators (max volume 1.5 mL) or into 25 capillary tubes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section.
- •Informed consent collected from subject able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
- •Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.
排除标准
- •Subjects with known infectious disease such as Hepatitis C or HIV (to ensure the operator safety).
结局指标
主要结局
ABL90 FLEX PLUS Clinical Precision
时间窗: 5 hours
Repeatability (SD) for each parameter (ctBil and FHbF), parameter level and measuring mode, pooled across sites.
次要结局
未报告次要终点