Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading
研究概览
简要总结
CRRT patients are generally critical ill patients with unstable conditions, such as low blood pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit. Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and heparin induced thrombocytopenia in such cases.However, the problem of CRRT without anticoagulation is the early filter clotting. An alternative method is the use of heparin coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane hemofilter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
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
- •Critical ill patients who need continuous renal replacement therapy
- •Continuous anticoagulation therapy is not necessarily during CRRT process
排除标准
- •Patients needing continuous anticoagulation during each CRRT process
- •Expectant survival time less than 72 hours
- •Extremely unstable vital signs such as low blood pressure
- •Any reasons that resulting in blood flow rate less than 150ml/min
- •Pregnant women
- •Patients allergic to heparin
结局指标
主要结局
The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading
时间窗: 6 months
The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process
时间窗: 6 months
The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter
时间窗: 6 months
次要结局
- The number of participants with the adverse events.(6 months)
研究者
Tao Su
Effect of heparin coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients
Peking University First Hospital