Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The endogenous thrombin potential (ETP) will be measured.
研究概览
简要总结
ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female age ≥ 18 years old
- •Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care
- •Informed consent
排除标准
- •Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device
- •Contraindication to curative anticoagulation
- •Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary hemorrhagic telangiectasia, etc.)
- •History of heparin-induced thrombocytopenia
- •Moribund patient at the day of inclusion
- •Do Not Resuscitate decision
- •Subject under the protection of justice
- •Subject under guardianship or curatorship
- •Pregnancy
- •Breastfeeding
结局指标
主要结局
The endogenous thrombin potential (ETP) will be measured.
时间窗: daily from Day1 to Day10 and at each dosing of anti-Xa.
次要结局
- Levels of markers of vascular cell activation(daily from Day1 to Day10)
- Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis(daily from Day1 to Day10)
- Mortality: number of patients who are dead by day 28(day 28)
- Levels of hemostasis parameters:(daily from Day1 to Day10)
- Incidence of bleeding events defined by the WHO classification,(daily from Day1 to Day10)