Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?
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
- 否
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
Sandra Jonmarker
Principal investigator, MD, PhD-student
Karolinska Institutet
