Intravenous Continuous LMWH (enoxaparin) Seems to Be Safe Alternative to UFH in Patients with VV ECMO
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
- 否
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
Durila Miroslav MUDr. Ph.D.
prof.MD. Miroslav Durila, Ph.D., MHA
University Hospital, Motol
