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临床试验/NCT04671160
NCT04671160Unknown不适用

Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Anti-Xa assay

研究概览

简要总结

Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.

详细描述

Coagulation disorders are one of the most common complications in critically ill patients. Among them deep vein thrombosis and pulmonary embolism are the most significant factors increasing morbidity and mortality in ICU patients. Use of anticoagulant prophylaxis aims to prevent these dangerous complications. Most commonly used anticoagulant prophylaxis agents are low molecular weight heparins (LMWH). LMWH therapeutic efficiency is measured with activity of anti-Xa factor, that should range between 0.2 and 0.4 IU/mL in order to prevent thrombotic complications. Due to grave general condition, critically ill patients may often develop acute kidney injury (AKI), that requires renal replacement therapy (RRT). Because of haemodynamic instability the safest therapeutic choice seems to be continuous veno-venous hemodiafiltration (CVVHDF). This RRT mode removes particles in the size of few daltons even up to 10 kilodaltons (kDa) such as metabolic product waste, ions, hormones etc. LMWH with average molecular weight of 4.5 kDa and fondaparinux with average molecular weight of 1.7 kDa may be removed during CVVHDF resulting in insufficient activity of anti-Xa factor thus increasing the risk of thrombotic complications in critically ill 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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult Intensive Care Unit patients between 18 and 80 years old requiring treatment with CVVHDF;
  • Indications for anticoagulant prophylaxis with enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily;
  • Treatment with continuous veno-venous hemodiafiltration.

排除标准

  • Indications for low molecular weight heparin use other than anticoagulant prophylaxis;
  • Intracranial hemorrhage;
  • Incident of serious bleeding within a week before admission to ICU, if not managed;
  • Disseminated intravascular coagulopathy;
  • Heparin induced thrombocytopenia;
  • Hypersensitivity or allergic reaction to enoxaparin or fondaparinux;
  • Thrombocytopenia < 50 G/L;
  • Prothrombin time < 20% or INR (international normalized ratio) > 1.7;
  • Use of antiplatelet drugs;
  • Presence of congenital coagulopathy.

结局指标

主要结局

Anti-Xa assay

时间窗: 9 hours

Anti-Xa assay as a tool to measure anticoagulation activity in subjects just before administration of anticoagulant prophylaxis, 3 hours, 6 hours and 9 hours after administration of prophylactic dose of enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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