Reduced Anticoagulation Targets in ECLS (RATE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 8
- 主要终点
- Hemorrhagic complications
研究概览
简要总结
The objective of the RATE-trial is to study if reduced anticoagulation targets during ECLS diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
详细描述
Rationale: ECMO treatment has a mortality of 38%, for a large part treatment related due to complications. The most feared complication is ischemic stroke for which heparin is administered with an aPTT target 2.0-2.5 times baseline (approximately 60-75 sec).
However, there is no relation between aPTT and the occurrence of stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome.
Objective: Our objective is to study if reduced anticoagulation targets diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
Study design: Three-arm non-inferiority RCT.
Study population: All adult Dutch patients treated with ECMO during the 30 months of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •ECMO treatment during the study period in one of the participating centers
- •Age above 18 years
- •Written informed consent
排除标准
- •Patients in whom the ECMO is only used to bridge a procedure
- •Vital indication for robust anticoagulation (e.g. mechanic valve, pulmonary embolism)
- •History of heparin induced thrombocytopenia
研究组 & 干预措施
Target of 2-2.5 times baseline aPTT (usual care, about 60-75)
Administration of heparin during ECLS with an aPTT target of 2-2.5 times baseline.
干预措施: Heparin (Drug)
Target of 1.5-2.0 times baseline aPTT (45-60 sec.)
Administration of heparin during ECLS with an aPTT target of 1.5-2.0 times baseline.
干预措施: Heparin (Drug)
LMWH guided by weight and renal function.
Administration of LMWH guided by weight and renal function during ECLS.
干预措施: LMWH (Drug)
结局指标
主要结局
Hemorrhagic complications
时间窗: Through ECLS completion, an average of 14 days
Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of ≥ 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.
Severe thromboembolic complications
时间窗: Through ECLS completion, an average of 14 days
Severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure
Mortality
时间窗: 6 months after ECLS
Mortality at 6 months
次要结局
- All thromboembolic complications combined(Through ECLS completion, an average of 14 days)
- Number of blood transfusions(Through ECLS completion, an average of 14 days)
- Quality of life at 6 months(6 months after ECLS)
- Exchange of the membrane oxygenator(Through ECLS completion, an average of 14 days)
- Vessel thrombosis after ECLS removal(After ECLS completion, an average of 14 days)
- Cost- effectiveness(6 months after ECLS)
- Pulmonary embolism(Through ECLS completion, an average of 14 days)
研究者
Walter M. van den Bergh
Principal investigator
University Medical Center Groningen