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临床试验/NCT05256524
NCT05256524已完成不适用

Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 1,520 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,520
试验地点
1
主要终点
Mortality

研究概览

简要总结

Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients with critical COVID-19 and respiratory failure
  • Positive SARS-CoV-2 test
  • LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime

排除标准

  • Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
  • Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

研究组 & 干预措施

Patients with critical COVID-19 responding to LMWH treatment

Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

干预措施: The effect of LMWH (Drug)

Patients with critical COVID-19 responding to LMWH treatment

Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

干预措施: Monitoring frequency of aFXa-levels (Diagnostic Test)

Patients with critical COVID-19 not responding to LMWH treatment

Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

干预措施: The effect of LMWH (Drug)

Patients with critical COVID-19 not responding to LMWH treatment

Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

干预措施: Monitoring frequency of aFXa-levels (Diagnostic Test)

结局指标

主要结局

Mortality

时间窗: 90 days from ICU admission

90-day mortality

次要结局

  • Thromboembolic events(28 days from ICU-admission)
  • Bleeding events(28 days from ICU-admission)

研究者

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

Sandra Jonmarker

Principal investigator, MD, PhD-student

Karolinska Institutet

研究点 (1)

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