Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- incidence of ECMO related thrombotic events
研究概览
简要总结
Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 V-V ECMO because of sevever respiratory failure
排除标准
- •anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.
研究组 & 干预措施
argatroban group
Patients received argatroban for anticoagulation during V-V ECMO.
干预措施: Argatroban (Drug)
UFH group
Patients received UFH for anticoagulation during V-V ECMO.
干预措施: unfractionated heparin (Drug)
结局指标
主要结局
incidence of ECMO related thrombotic events
时间窗: 14 days
the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.
次要结局
未报告次要终点
研究者
Bing Sun
Professor
Beijing Chao Yang Hospital