A Novel Strategy Combined Regional Anticoagulation in Membrane Oxygenator and Low-intensity of Systemic Anticoagulation Applied in Management of Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- incidence of ECMO related bleeding or thrombotic events
研究概览
简要总结
ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •age older than 18 years old
- •received VV ECMO because of severe respiratory failure
排除标准
- •anticoagulant contraindications
- •cerebral infarction or suspected patients
- •severe hypertension
- •women in gestational and lactational period
- •hemophilia
- •allergic to heparin or Nafamostat
- •unwilling or unable to complete the study
研究组 & 干预措施
New Anticoagulation Strategy Group
Combination of nafamostat and unfractionated heparin for anticoagulation, adjusting the dosage of unfractionated heparin to maintain APTT in the body for 40-45 seconds, and adjusting the dosage of nafamostat to maintain APTT in the membranous lung for 50-60 seconds during ECMO
干预措施: Nafamostat (Drug)
control group
Anticoagulation with unfractionated heparin, regulating the dosage of unfractionated heparin to maintain APTT in the body for 50-60s during ECMO.
干预措施: Heparin (Drug)
结局指标
主要结局
incidence of ECMO related bleeding or thrombotic events
时间窗: 28 days
the incidence of ECMO related bleeding or thrombotic events,such as membrane oxygenator or tube thrombotic,local blooding.
次要结局
- Types and specific incidence rates of ECMO-related bleeding and thrombotic events(28 days)
- Time from ECMO initiation to bleeding and thrombotic events(28 days)
- ECMO duration(28 days)
- Blood product transfusion(28 days)
- Mortality(60 days)