Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of severe bleeding during ECMO
研究概览
简要总结
The purpose of this study was to compare the efficacy and safety of nafamostat mesylate and unfractionated heparin during ECMO anticoagulation in critically ill patients.
详细描述
During ECMO treatment, nafamostat mesylate and unfractionated heparin were randomly administered for continuous anticoagulation, respectively, and the incidence of bleeding and thrombotic complications during anticoagulation was compared between the two groups.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >= 18 and <= 80 years;
- •Successfully established ECMO (VA/VV) treatment by percutaneous puncture due to cardiogenic shock or respiratory failure;
- •Anticoagulation required during ECMO treatment; Before the establishment of ECMO, the APTT test value was within the normal range, and the platelets were not less than 80G/L;
- •Within 48 hours of ECMO establishment, APTT test results were between 1 and 1.75 times the upper limit of normal, PLT>80 G/L, and no serious bleeding and thrombosis;
- •Sign the informed consent.
排除标准
- •Pregnant;
- •Bleeding risk or active bleeding;
- •Pre-existing diseases requiring long-term anticoagulation before ECMO: pulmonary embolism, deep vein thrombosis, intraventricular thrombosis, atrial fibrillation, etc.;
- •Long-term use of anticoagulants before ECMO;
- •Antiplatelet drugs were used before ECMO;
- •Allergy to heparin, nafamostat mesylate;
- •Repeated puncture at the same site for more than 3 times;
- •Expected ECMO treatment time < 3 days;
- •Patients with an expected survival period of less than 48 hours;
- •Patients undergoing extracorporeal cardiopulmonary resuscitation;
- •Burn patients; Blood purification treatment using polyacrylonitrile membrane filter;
- •Heterozygous ECMO mode or ECMO therapy solely for CO2 removal;
- •Other reasons that the investigator considers inappropriate for inclusion;
研究组 & 干预措施
Nafamostat Mesylate
VV-ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
干预措施: Nafamostat Mesylate (Drug)
Unfractionated Heparin
VV-ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
干预措施: Unfractionated Heparin (Drug)
结局指标
主要结局
Incidence of severe bleeding during ECMO
时间窗: Up to 14 days.
The ratio of the number of patients with severe bleeding complications to the total number of cases in each group.
次要结局
- Incidence of thrombosis during ECMO(Up to 14 days.)
- Oxygenator replacement frequency(Up to 14 days.)
- The incidence of ECMO dysfunction(Up to 14 days.)
- Bleeding-free days during ECMO(Up to 14 days.)
- The compliance rate of APTT test results(Up to 14 days.)
- In-hospital mortality(Through study completion, an average of 2 months.)
- Average length of hospital stay(Through study completion, an average of 2 months.)
- The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day(Up to 14 days.)
- Case fatality rate within 28 days(Up to 28 days.)
- Average length of ICU stay.(Through study completion, an average of 2 months.)
研究者
Xiaobo Yang, MD
Clinical Professor
Wuhan Union Hospital, China