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临床试验/NCT05926518
NCT05926518已完成不适用

Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Evaluation of anti-Xa peak level

研究概览

简要总结

Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.

Secondary objectives

  1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
  2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.

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

  • All COVID-19 patients > 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc
  • All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.
  • Minimum estimated length of stay on the ICU of 4 days

排除标准

  • o (History of) Heparin Induced Thrombocytopenia and Thrombosis

结局指标

主要结局

Evaluation of anti-Xa peak level

时间窗: 2 years

U/ml

次要结局

  • Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level(2 years)
  • Percentage of anti-Xa levels within target range(2 years)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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