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临床试验/NCT05221879
NCT05221879已完成不适用

Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin

研究概览

简要总结

Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.

排除标准

  • Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance < 30 mL/min.

结局指标

主要结局

Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin

时间窗: Up to 72 hours from ICU admission.

We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sara dichtwald

Dr

Meir Medical Center

研究点 (1)

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