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临床试验/NCT05224388
NCT05224388已完成不适用

Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 813 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
813
试验地点
1
主要终点
Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range

研究概览

简要总结

To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.

详细描述

COVID-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. This pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding COVID-19. Current literature shows that COVID-19 patients have an increased risk for thrombo-embolic events which is why patients at the Ghent university hospital get increased dose of thrombo-prophylactic therapy. Patients were also screened for presence of deep venous thrombosis using ultrasound.

Anti-Xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor Xa. Using this test allowed us to measure the effect of our UF of LWMH and adjust the dose if needed.

At this moment It is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. We also looked into the time it took for anti-Xa to reach adequate levels in our dosing regimen. Furthermore, current risk factors for thromboembolic complications in COVID-19 patients are still unclear. We compared the results of the COVID-19 patients to a group of critical ill patients without COVID-19.

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

  • 18 years or older
  • Hospitalisation required
  • ICU admission

排除标准

  • Coagulopathies prior to COVID 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, ...)
  • Therapeutic anticoagulation on moment of ICU admission
  • Major trauma
  • Major bleeding
  • Cerebro vascular accident or neuro trauma in the last month

研究组 & 干预措施

Critically ill, prophylactic dose regimen

Prophylaxis of deep vein trombosis in critically ill patients

干预措施: Enoxaparin (Drug)

Critically ill, prophylactic dose regimen

Prophylaxis of deep vein trombosis in critically ill patients

干预措施: Heparin (Drug)

Critically ill, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in critically ill patients

干预措施: Enoxaparin (Drug)

Critically ill, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in critically ill patients

干预措施: Heparin (Drug)

Covid, prophylactic dose regimen

Prophylaxis of deep vein trombosis in Covid patients

干预措施: Enoxaparin (Drug)

Covid, prophylactic dose regimen

Prophylaxis of deep vein trombosis in Covid patients

干预措施: Heparin (Drug)

Covid, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in Covid patients

干预措施: Enoxaparin (Drug)

Covid, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in Covid patients

干预措施: Heparin (Drug)

结局指标

主要结局

Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range

时间窗: 36 hours

36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured

次要结局

  • Possible risk factors for thrombo-embolic complications in COVID-19 patients(Time of discharge or death)
  • Safety of increased dose of thromboprophylaxis in Covid-19 patients(Time of discharge or death)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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