Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 主要终点
- Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
研究概览
简要总结
This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. The results will be compared to a "gold standard" sample taken from an arterial catheter (KTA) whithout UFH. The objective is to identify a more reliable method for monitoring UFH, thereby reducing the risk of bleeding or thrombosis in these patients.
详细描述
- Scientific Justification: UFH is widely used in pediatric cardiac intensive care for its short half-life and availability of an antidote. However, monitoring its effect via anti-Xa activity is challenging. The standard method of sampling from a CVC is known to be prone to heparin contamination, leading to inaccurate results (over- or under-anticoagulation). This lack of precision can lead to dangerous complications like major bleeding or thrombotic events. As studies by Palermo et al. (1980) and Bauman et al. (2012) have shown, the unreliability of CVC samples justifies the search for a safer alternative. The arterial catheter (KTA) provides a contamination-free "gold standard," making it the ideal comparison for evaluating the more reliable sampling method.
- Procedure: The study will compare two CVC sampling methods (a standard flush protocol and a new experimental method) against the gold standard (KTA sampling without UFH)
- Follow-up: The study will be conducted over three consecutive days. Each day, three sets of blood samples will be collected every 6 hours per patient (KTA, standard CVC, and experimental CVC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minors aged 0 to 17 inclusive
- •Weight greater than or equal to 3.5 kg
- •Admitted to resuscitation or congenital cardiac intensive care
- •Requiring treatment with unfractionated heparin at curative doses administered via central venous access
- •Equipped with a central arterial and venous catheter
- •Affiliated with or beneficiary of a social security scheme
- •Free, informed, and written consent signed by one of the two representatives of parental authority and the investigator (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Newborns < 37 weeks gestation
- •Patients treated by a humanitarian organization
研究组 & 干预措施
anti-Xa activity monitoring
All patients included in the study
干预措施: blood sampling for measuring anti-Xa activity (Procedure)
anti-Xa activity monitoring
All patients included in the study
干预措施: measurement of anti-XA activity (Procedure)
结局指标
主要结局
Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
时间窗: "From enrollment to the end of study at 72hours"
Anti-Xa activity and APTT measurements will be performed at the university hospital's central laboratory, which guarantees the consistency of the reagents, automated systems, and techniques used. The recommended therapeutic target is between 0.3 and 0.6 IU/mL.
次要结局
- Measurement of APTT from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).("From enrollment to the end of study at 72 hours")
- Measurement of APTT and anti-Xa activity (in IU/mL) from a sample taken from a non-heparinized arterial catheter (i.e., gold standard)(From enrollment to the end of study at 72 hours)