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临床试验/NCT06010446
NCT06010446已完成不适用

Intravenous Continuous LMWH (enoxaparin) Seems to Be Safe Alternative to UFH in Patients with VV ECMO

University Hospital, Motol1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年5月15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
43
试验地点
1
主要终点
Incidence of major bleeding complications

研究概览

简要总结

Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients.

We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications.

详细描述

Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may protect ECMO from thrombotic complication as primary haemosthasis plays major role in haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is connected with lower incidence of bleeding complication and HIT (heparin induced thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.

We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications. We want to compare this incidence of compliactions with data known from patients with other studies using UFH.

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

  • VV ECMO - use of 2 separate cannulas (jugular and femoral)
  • anticoagulation with only intravenous continuous LMWH (Enoxaparin)
  • only a period of the first ECMO set running

排除标准

  • pregnancy
  • Avalon cannula (one double lumen cannula)
  • patients after thoraco-abdominal surgery
  • patients after lung transplantation in early postoperative period
  • patients after trauma without any type of heparin ,,heparin free" ECMO

结局指标

主要结局

Incidence of major bleeding complications

时间窗: Daty from may 2019 till august 2023

Defined by ECMO registry

Incidence of major thrombotic complications

时间窗: Daty from may 2019 till august 2023

Defined by ECMO registry

Incidence of major neurologic complications

时间窗: Daty from may 2019 till august 2023

Defined by ECMO registry

次要结局

未报告次要终点

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Durila Miroslav MUDr. Ph.D.

prof.MD. Miroslav Durila, Ph.D., MHA

University Hospital, Motol

研究点 (1)

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