A Randomized Controlled Pilot Trial of When Heparin Stopped for Anticoagulation During Extracorporeal Membrane Oxygenation Decannulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of bleeding and clotting complications
研究概览
简要总结
Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Heparin infusion is regulated to keep the whole blood activated clotting time (ACT) or activated partial thromboplastin time (APTT) at a designated level (usually 1.5 times normal for the ACT or APTT measurement system). An elevated ACT or APTT is associated with high risks of early and late complications,such as bleeding,hematoma,pseudoaneurysm,and arterial-venous fistula. Extracorporeal life support organization(ELSO) make recommendation that the cannulas can be removed ideally after the heparin has been stopped for 30 to 60 minutes.However,the Chinese Thoracis Society recommends that heparin should not be discontinued immediately before ECMO decannulation, but gradually reduced within 24 hours, and then low molecular weight heparin is continued to be given for anticoagulation. Therefore,options of which time heparin stopped remain controversial.The investigators conduct this pilot study to investigate the opportunity of heparin stopped for anticoagulation before ECMO decannulation.
详细描述
Forty adult patients with cardiac or respiratory failure supported by ECMO are enrolled in the study. Patients are randomly allocated to be treated with either a) heparin has been stopped for 1 hour before ECMO decannulation(regimen A), b) heparin gradually reduced within 24 hours after ECMO decannulation(regimen B).The investigators hypothesize that patients treated with regimen A as compared with patients treated with regimen B would decrease the incidence of complications during the ECMO decannulation period(from 1 hour before ECMO decannulation to 72 hours post decannulation).
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
- Double (Participant, Outcomes Assessor)
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
- •ECMO therapy was instituted to support circulatory and/or respiratory failure;
- •Heparin continuous infusion for anticoagulation during ECMO;
- •Native cardiac and pulmonary function improve,and the trial off is successful.
- •Ensure each patient provides signed and dated informed consent.
排除标准
- •1.History of thrombotic diseases or coagulation disorder；
- •Thrombosis or bleeding events occurred prior to allocation；
- •Heparin stopped prior to allocation；
- •Other anticoagulants, antiplatelets, hemostatics and other drugs affected coagulation function have been used；
- •The trial off has failed;
- •Pregnant and lactating patients;
- •Patients participated in the other studies;
- •Patients couldn't accept comprehensive treatment;
- •Patients couldn't acquire informed consent;
结局指标
主要结局
Incidence of bleeding and clotting complications
时间窗: 72 hours after decannulation
次要结局
- International normalised ratio(1 day and 3 days after decannulation)
- 28-days mortality(28 days after decannulation)
- Prothrombin time(1 day and 3 days after decannulation)
- Volume of packed red cells transfusion(3 days after decannulation)
- D-dimer(1 day and 3 days after decannulation)
- R time(1 day and 3 days after decannulation)
- ICU mortality(1 day after ICU discharge)
- Activated partial thromboplastin time(1 day and 3 days after decannulation)
- Fibrinogen(1 day and 3 days after decannulation)
- K time(1 day and 3 days after decannulation)
- α angle(1 day and 3 days after decannulation)
- Maximum amplitude（MA）(1 day and 3 days after decannulation)
- LY30(1 day and 3 days after decannulation)