D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Thrombotic events
研究概览
简要总结
This was a prospective, cohort study.
详细描述
Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort. Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). All patients were followed up The occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients
- •Receiving ECMO surpport for any reason
排除标准
- •The duration of ECMO surpport was less than 24 hours .
- •Those who had difficulty in compliance or were unavailable for follow-up.
研究组 & 干预措施
DIAMOND group
D-dimer and anti-Xa are mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).
干预措施: D-dimer-guided adjustment stratege (Diagnostic Test)
Control group
Heparin dose adjusted according to anti-Xa activity or activated partial thromboplastin time (aPTT). The target range is aPTT 1.5 to 2.5 times the upper limit of normal or therapeutic anti-Xa levels (0.3 U/ml to 0.7 U/ml) for unfractionated heparin.
干预措施: Thepeautic-heparin therapy (Diagnostic Test)
结局指标
主要结局
Thrombotic events
时间窗: 24 months
Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
hemorrhagic events
时间窗: 24 months
cerebral hemorrhage,Gastrointestinal bleeding etc.
次要结局
- all-cause deaths(24 months)
研究者
Litao Zhang
Director of Thrombosis centre
Wuhan Asia Heart Hospital