BACKGROUND Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. METHOD In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-2 and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-2 and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded. RESULTS Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was significantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240, P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P > 0.05. CONCLUSIONS Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. TRIAL REGISTRATION GDREC, GDREC2017250H. Registered February 2, 2018; retrospectively registered.

中文翻译：

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改良的柠檬酸局部抗凝治疗最适合出血风险高的患者进行血液透析：对三种抗凝策略的前瞻性随机研究。

背景技术推荐的定期盐水冲洗对具有肝素禁忌症高出血风险的血液透析（HD）患者表示临床无效。以前，柠檬酸抗凝剂（RCA）曾与含Ca2 +的透析液一起使用，而透析液中的柠檬酸已在一只手臂中过滤（RCA-one）。但是，抗凝并非总是可以实现的，最多40％会导致静脉扩张腔中严重凝结。在这项研究中，我们已经将四分之一的TSC从基于RCA-一的预过滤器转移到了后过滤器，我们将其称为RCA-二。这项研究的目的是比较RCA-2与盐水冲洗或RCA-1在具有高出血风险的HD患者中的疗效和安全性。方法在该研究者发起的，多中心，对照，前瞻性，随机临床试验中，在试验的第一部分中，将52名HD患者（77个疗程）随机分配到RCA-2和RCA-1组，在试验的第二个部分中，将45名患者（64个疗程）随机分配到RCA-2和盐水组。记录严重的凝血事件，不良事件和血液分析。结果RCA-2组的严重凝血事件明显低于RCA-1和盐水组（分别为7.89％vs. 30.77％，P = 0.011； 3.03％vs. 54.84％，P <0.001）。在RCA两组中，中位电路生存时间为240分钟（IQR 240至240），比在RCA一组中的230分钟（IQR 155至240，P <0.001）显着更长，而在210分钟（IQR 135至150 I 240，P = 0.003）。大部分不良事件为低血压，低血糖和胸闷，其中多数为轻度。八名患者（20。RCA 1组为51％），盐水组4例（12.90％），RCA 2组10例（26.31％），P> 0.05。结论我们的数据表明，对于高出血风险的患者，血液透析治疗期间改良的抗凝方案更为有效和可行。GDREC试用注册，GDREC2017250H。2018年2月2日注册; 追溯注册。