Su Tao, Jin Qizhuang, Liu Zhongyuan
Renal Division, Department of Medicine, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, 100034, China.
BMC Nephrol. 2017 Jun 30;18(1):208. doi: 10.1186/s12882-017-0627-1.
Critically ill patients requiring renal replacement therapy (RRT) are at risk of disease-related bleeding. Systemic heparinization should be avoided. AN69ST, a polyethyleneimine-treated polyacrylonitrile (AN69) membrane hemofilter, can be primed with heparin, improving its local anticoagulative activity. Prolonged intermittent RRT (PI-RRT) is of shorter duration and cheaper, considered as an alternative to continuous RRT. This study was performed to compare the success rate of anticoagulant-free PI-RRT using AN69ST versus AN69 membrane hemofilter. We also evaluated risk factors for filter clotting.
This crossover, double-blind, randomized study included patients requiring PI-RRT but at high bleeding risk treated with AN69ST and AN69 hemo filters. The success rate of RRT, filter lifespan and severity of filter clotting were compared between the hemo filters. Factors associated with the filter clotting risk were analyzed with a Cox proportional hazards model.
This study included 60 patients (mean age, 68.1 ± 15.8 years). Thirty-three (55.0%) patients were in the intensive care unit, 34 (56.8%) had disease-related thrombocytopenia, and 14 (23.3%) had local hemorrhagic diseases. The success rate of PI-RRT with the AN69ST and AN69 hemofilter was 51.7% and 50.9%, respectively (P > 0.05). The mean PI-RRT duration was 543.1 ± 119.0 min in the completed sessions and 387.3 ± 140.8 min in the prematurely terminated sessions, without significant difference between AN69ST and AN69 hemofilters. Cox regression analysis showed that age (odds ratio [OR], 1.023 per year), platelet count (OR, 1.07 per 10 × 10/L), hemoglobin concentration (OR, 1.035 per 1 g/L), and activated partial thromboplastin time (aPTT; OR, 0.973 per second) were associated with a hemofilter clotting risk. The AN69ST hemofilter lifespan was significantly prolonged averaging an extra 251.7 min in patients with an aPTT of <35.3 s, hemoglobin concentration of >83 g/L and platelet count of <70 × 10/L.
Anticoagulant-free PI-RRT by a heparin-primed AN69ST hemofilter reached a 51.7% success rate. The risk of premature clotting of the extracorporeal circuit remains unsatisfactory. For select patients at high risk of bleeding, the heparin-primed AN69ST hemofilter may be more appropriate for anticoagulation-free PI-RRT.
https://www.clinicaltrials.gov ; study number: NCT02355873 . Release Date 01/21/2015.
需要肾脏替代治疗（RRT）的重症患者存在与疾病相关的出血风险。应避免全身肝素化。AN69ST是一种经聚乙烯亚胺处理的聚丙烯腈（AN69）膜血液滤过器，可用肝素预充，可提高其局部抗凝活性。延长间歇性RRT（PI-RRT）持续时间较短且成本较低，被认为是持续RRT的替代方案。本研究旨在比较使用AN69ST与AN69膜血液滤过器进行无抗凝PI-RRT的成功率。我们还评估了滤器凝血的危险因素。
这项交叉、双盲、随机研究纳入了需要PI-RRT但出血风险高的患者，分别使用AN69ST和AN69血液滤过器进行治疗。比较两种血液滤过器的RRT成功率、滤器使用寿命和滤器凝血严重程度。采用Cox比例风险模型分析与滤器凝血风险相关的因素。
本研究纳入60例患者（平均年龄68.1±15.8岁）。33例（55.0%）患者在重症监护病房，34例（56.8%）患有与疾病相关的血小板减少症，14例（23.3%）患有局部出血性疾病。使用AN69ST和AN69血液滤过器进行PI-RRT的成功率分别为51.7%和50.9%（P>0.05）。在完成的疗程中，PI-RRT平均持续时间为543.1±119.0分钟，在提前终止的疗程中为387.3±140.8分钟，AN69ST和AN69血液滤过器之间无显著差异。Cox回归分析显示，年龄（比值比[OR]，每年1.023）、血小板计数（OR，每10×10/L为1.07）、血红蛋白浓度（OR，每1g/L为1.035）和活化部分凝血活酶时间（aPTT；OR，每秒0.973）与血液滤过器凝血风险相关。在aPTT<35.3秒、血红蛋白浓度>83g/L和血小板计数<70×10/L的患者中，AN69ST血液滤过器的使用寿命显著延长，平均延长251.7分钟。
使用肝素预充的AN69ST血液滤过器进行无抗凝PI-RRT的成功率为51.7%。体外循环过早凝血的风险仍不尽人意。对于部分出血风险高的患者，肝素预充的AN69ST血液滤过器可能更适合无抗凝PI-RRT。
https://www.clinicaltrials.gov；研究编号：NCT02355873。发布日期：2015年1月21日。
