Reduced anticoagulation targets in extracorporeal life support
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 7
- 主要终点
- The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.
研究概览
简要总结
Our primary research question is if anticoagulation with UFH with reduced anticoagulation targets or anticoagulation with low molecular weight heparin (LMWH) leads to a reduction in the occurrence of major bleeding without an increase in thromboembolic complications or a negative effect on outcome compared to the standard practice of high anticoagulation targets with UFH. We expect fewer complications and improvement of survival after ECMO therapy for both interventions.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •All adults receiving ECMO treatment at the ICU of one of the participating centers during the study period are eligible for inclusion.
排除标准
- •The exclusion criteria are as follows: (1) patients in whom the ECMO is only used to bridge a procedure like a high-risk percutaneous coronary intervention or during surgery; (2) no (deferred) informed consent; (3) vital indication for robust anticoagulation (e.g., mechanic mitral valve, pulmonary embolism, a clot in the cardiac ventricle); and (4) a history of heparin-induced thrombocytopenia (HIT).
结局指标
主要结局
The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.
The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.
次要结局
- Secondary outcome parameters are: 1) blood transfusions; 2) health related quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator; 4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; and 8) all thromboembolic complications combined.
研究者
Walter M. van den Bergh
Scientific
Universitair Medisch Centrum Groningen