Central Catheter Anti-Xa Sampling Study for Accurate aNalysis and Reliable Dosage Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in anti-Xa activity values between the two sampling sites.
研究概览
简要总结
The goal is to investigate whether blood samples drawn from a central venous catheter can provide reliable measurements of unfractionated heparin (UFH) anti-Xa activity, compared to the standard method of peripheral vein puncture, in intensive care unit (ICU) patients receiving continuous intravenous UFH.
To evaluate the reliability of central venous blood sampling, the study will compare anti-Xa activity levels obtained simultaneously from two different types of blood draws: one from a peripheral vein (reference method), and the other from the central line using one of two flushing techniques.
The two central flushing techniques being studied are:
- A 5 mL syringe flush performed over 5 seconds, followed by blood collection.
- A vacuum tube flush that draws and discards 5 mL of blood, followed by blood collection.
Each patient will undergo four pairs of simultaneous blood draws, using both central techniques in a randomized sequence. The main objective is to assess whether the anti-Xa levels from central samples are equivalent to those from peripheral vein puncture, with a predefined margin of equivalence of ±0.05 IU/mL.
Findings from this study may support the use of central venous catheters for routine anti-Xa monitoring in ICU patients, potentially avoiding painful or technically difficult peripheral vein punctures.
详细描述
Unfractionated heparin (UFH) is widely used in intensive care units (ICUs) and requires close monitoring, most commonly through the measurement of anti-Xa activity.
The reference method for anti-Xa monitoring involves blood sampling by peripheral vascular puncture. However, in ICU patients, peripheral access may be challenging or painful, and central venous catheters are often available and already used for UFH infusion. Sampling from these central lines could be a convenient alternative, but residual heparin in the catheter may contaminate the sample, leading to falsely elevated anti-Xa results.
The CASSANDRA study (Central catheter Anti-Xa Sampling Study for Accurate aNalysis and Reliable Dosage Assessment) is a prospective, monocentric, comparative study designed to assess whether anti-Xa activity levels obtained from central venous catheter samples are equivalent to those from peripheral vein samples.
To be eligible for inclusion, patients must already have a central venous catheter in place and require continuous intravenous unfractionated heparin administration through the distal lumen of the central venous catheter.
A three-way stopcock will be placed upstream of the infusion tubing to allow temporary interruption of UFH infusion during sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Person (or support person/relative if unable to do so) who has agreed to participate in the study
- •18 years of age or older
- •Hospitalized in intensive care medicine
- •Having a central venous catheter with at least three lumens (internal jugular, subclavian or femoral) already in place
- •Receiving continuous intravenous unfractionned heparin, with target Anti-Xa activity between 0.3 and 0.7 IU/ml.
排除标准
- •Protected person (under guardianship or curatorship)
- •Person under court protection
- •Person deprived of liberty
- •Person not affiliated to the French social security
- •Pregnant or breast-feeding woman
研究组 & 干预措施
Sequence A, B, A, B
First and third samples with syringe flush; second and fourth with vacuum tube flush
干预措施: catheter flushing techniques (Procedure)
Sequence A, B, B, A
First and fourth samples with syringe flush; second and third with vacuum tube flush
干预措施: catheter flushing techniques (Procedure)
Sequence B, A, B, A
Second and fourth samples with syringe flush; first and third with vacuum tube flush
干预措施: catheter flushing techniques (Procedure)
Sequence B, A, A, B
Second and third samples with syringe flush; first and fourth with vacuum tube flush
干预措施: catheter flushing techniques (Procedure)
结局指标
主要结局
Difference in anti-Xa activity values between the two sampling sites.
时间窗: From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28
Difference in anti-Xa activity values between the two sampling sites: central venous catheter with a 5 mL discard using either a syringe or a vacuum tube, versus peripheral vein puncture, the latter being considered the reference method. Equivalence is defined a priori as a mean absolute difference not exceeding 0.05 IU/mL of anti-Xa activity.
次要结局
- Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method A (5 mL syringe discard) and peripheral vein puncture.(From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28)
- Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method B (5 mL vacuum tube discard) and peripheral vein puncture.(From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28)