Unfractionated Heparin in COVID-19 and Non-COVID-19 Patients - an Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Heparin dosage
研究概览
简要总结
The majority of ICU patients with COVID-19 show profound activation of coagulation, potentially resulting in thromboembolic events. In the treatment of these thromboembolic events it seemed that very high dosages of unfractionated heparin were necessary to achieve therapeutic values of aPTT and anti-Xa levels. The aim of this study is to explore whether heparin dosages are higher in COVID-19 patients compared to non-COVID-19 patients, to determine the correlation between aPTT and anti-Xa values and to explore possible causes for non-correlating aPTT and anti-Xa, including CRP and AT plasma levels.
详细描述
CoVID-19 is a viral disease caused by SARS-CoV-2 virus that may affect many organ systems. Patients with severe disease almost invariably have profound pulmonary inflammation and may require mechanical ventilation and prolonged ICU admission. Mortality in ICU patients may be up to 50%. In the majority of patients with CoVID-19 in the ICU, profound activation of coagulation is present as reflected by d-dimer levels up to 20.000 mg/L or higher. Patients with proven pulmonary thrombosis are commonly treated with unfractionated heparin (UFH). Typically, it seemed that very high dosages of UFH were necessary to achieve therapeutic values of aPTT and anti-Xa levels in COVID-19 patients. Though, the question remains whether dosages given in COVID-19 patients were indeed extravagant compared to non-COVID-19 patients and what potential causes of these high dosages might be. Earlier research already implied that APTT, which is a primarily used parameter to dose UFH, is not accurate and rather anti-Xa levels should be used. Other potential reasons for the high doses are that COVID-19 patients show signs of heparin resistance, possible due to high inflammation parameters. As overdosing of heparin can lead to serious bleeding complications, more understanding on heparin dosage, e.g. parameters to rely on and potential influencing factors, in COVID-19 patients is needed. The primary objective of this study is to determine whether heparin dosages are higher in COVID-19 patients compared to non COVID-19 patients. The secondary objective is to determine the correlation between aPTT and anti-Xa values and to explore possible causes for non-correlating aPTT and anti-Xa, including CRP and AT plasma levels.
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
- 未提供
排除标准
- •Treatment with anticoagulants other than UFH or fibrinolytics
研究组 & 干预措施
Covid-19 patients
Adult patients treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml. All patients have Covid-19 proven by PCR or nose- or airway swab. Patients admitted to the ICU from the 15th of March 2020 until January 2022.
干预措施: Unfractionated heparin (Drug)
non-COVID-19 patients
Adult patients treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml. Patients admitted to the ICU between the 1st of January 2014 and the 1st of January 2020 are included.
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Heparin dosage
时间窗: Until end of heparin therapy or ICU discharge, whatever comes first.
To determine whether heparin dosages are higher in COVID-19 patients compared to non COVID-19 patients.
次要结局
- Correlation between non-correlating aPTT and Anti-Xa levels and CRP(Until end of heparin therapy or ICU discharge, whatever comes first.)
- Correlation between aPTT and anti-Xa values(Until end of heparin therapy or ICU discharge, whatever comes first.)
- Correlation between non-correlating aPTT and Anti-Xa levels and AT plasma levels(Until end of heparin therapy or ICU discharge, whatever comes first.)
研究者
edejonge
Head of the Intensive Care Department
Leiden University Medical Center
