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临床试验/NCT07200674
NCT07200674招募中不适用

Interest of High-speed Centrifugation for Measuring Anti-Xa Activity on Lipemic Plasma

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma

研究概览

简要总结

Some hemostasis techniques require spectrophotometric measurements. These are then subject to interference from the sample's lipemia (postprandial, hypertriglyceridemia, etc.), which risks distorting the results; this is estimated to affect 0.5 to 2.5% of samples.

This is particularly the case for anti-Xa activity, a critical test used to monitor anticoagulant treatments.

To date, the HUS Hematology Laboratory does not have or is aware of any alternative method to overcome this interference, and is unable to perform anti-Xa activity when the sample has excessive lipemia. This study will evaluate, on samples from routine care artificially overloaded with lipids, the effectiveness of a high-speed centrifugation process (10,800g for 10 minutes).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (≥ 18 years)
  • Patient anticoagulated with an anti-Xa (UFH, LMWH, fondaparinux, danaparoid, apixaban, rivaroxaban)
  • Sample sent to the HUS Hematology Laboratory and analyzed for measurement of the anti-Xa activity of an anticoagulant as part of routine care

排除标准

  • Patient with a basal lipidemic sample
  • Sample of insufficient volume

结局指标

主要结局

To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma

时间窗: Up to 10 minutes

To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma, in order to measure anti-Xa activity, and to ensure that this process does not interfere with this measurement.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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