Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of thrombotic complications
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.
详细描述
Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO
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
- •Age ≥ 18 years old
- •VA-ECMO or VV-ECMO was accepted after cardiac surgery.
- •The ECMO treatment team believes that systemic anticoagulation is needed
- •Sign the informed consent form
排除标准
- •The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
- •Long-term use of anticoagulants before establishment of ECMO
- •Antiplatelet drugs were used before the establishment of ECMO
- •Severe liver insufficiency
- •Connective tissue disease
- •There is a history of allergy to heparin or nemolastat mesylate.
- •Previous diagnosis of heparin-induced thrombocytopenia
- •Expect to die within 48 hours
研究组 & 干预措施
nafamostat mesilate group
The initial dosing of the nafamostat mesilate group is 0.5mg/kg/h. We maintain ACT at 180~220s by adjusting the dosage of nafamostat mesilate.
干预措施: nafamostat mesilate (Drug)
unfractionated heparin group
The initial dosing of the unfractionated heparin group is 8~12U/kg/h. We maintain ACT at 180~220s by adjusting the dosage of unfractionated heparin .
干预措施: unfractionated heparin group (Drug)
结局指标
主要结局
Incidence of thrombotic complications
时间窗: Within 7 days after starting anticoagulant therapy
Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction.
次要结局
- Incidence of severe bleeding complications(Within 7 days after starting anticoagulant therapy)
- Infusion volume of blood products(Within 7 days after starting anticoagulant therapy)
- ACT qualified rate(Within 7 days after starting anticoagulant therapy)
- Hospitalization mortality(28 days)
- The incidence of oxygenator dysfunction(Within 7 days after starting anticoagulant therapy)
- Heparin-induced thrombocytopenia(Within 7 days after starting anticoagulant therapy)
- Time to reach the target anticoagulant level for the first time(Within 7 days after starting anticoagulant therapy)
研究者
Xiaotong Hou
Clinical professor
Beijing Anzhen Hospital