Application of regional citrate anticoagulation in patients at high risk of bleeding during intermittent hemodialysis: a prospective multicenter randomized controlled trial

Abstract

Objective

Safe and effective anticoagulation is essential for hemodialysis patients who are at high risk of bleeding. The purpose of this trial is to evaluate the effectiveness and safety of two-stage regional citrate anticoagulation (RCA) combined with sequential anticoagulation and standard calcium-containing dialysate in intermittent hemodialysis (IHD) treatment.

Methods

Patients at high risk of bleeding who underwent IHD from September 2019 to May 2021 were prospectively enrolled in 13 blood purification centers of nephrology departments, and were randomly divided into RCA group and saline flushing group. In the RCA group, 0.04 g/mL sodium citrate was infused from the start of the dialysis line during blood draining and at the venous expansion chamber. The sodium citrate was stopped after 3 h of dialysis, which was changed to sequential dialysis without anticoagulant. The hazard ratios for coagulation were according to baseline.

Results

A total of 159 patients and 208 sessions were enrolled, including RCA group (80 patients, 110 sessions) and saline flushing group (79 patients, 98 sessions). The incidence of severe coagulation events of extracorporeal circulation in the RCA group was significantly lower than that in the saline flushing group (3.64% vs. 20.41%, P<0.001). The survival time of the filter pipeline in the RCA group was significantly longer than that in the saline flushing group ((238.34±9.33) min vs. (221.73±34.10) min, P<0.001). The urea clearance index (Kt/V) in the RCA group was similar to that in the saline flushing group with no statistically significant difference (1.12±0.34 vs. 1.08±0.34, P=0.41).

Conclusions

Compared with saline flushing, the two-stage RCA combined with a sequential anticoagulation strategy significantly reduced extracorporeal circulation clotting events and prolonged the dialysis time without serious adverse events.

Abstract

目的

安全有效的抗凝治疗对于高危出血风险的血液透析患者至关重要。本试验的目的是评估应用标准含钙透析液进行双段法局部枸橼酸（RCA）联合序贯抗凝在间歇性血液透析（IHD）治疗中的有效性和安全性。

方法

前瞻性纳入13个肾内科血液净化中心2019年9月至2021年5月行IHD的出血高危患者，随机分为RCA组和生理盐水冲洗组。RCA组使用0.04 g/mL枸橼酸钠分别从透析管路的引血端及静脉壶双段输注，透析3小时后停用枸橼酸钠，并改为无抗凝剂模式序贯透析。根据基线计算凝血风险比。

结果

共纳入159名患者208例次，包括RCA组（80名，110例次）和盐水冲洗组（79名，98例次）。RCA组体外循环管路严重凝血事件的发生率明显低于生理盐水冲洗组（3.64% vs. 20.41%，P<0.001）。RCA组滤器管路的生存时间较生理盐水冲洗组明显延长（(238.34±9.33) min和(221.73±34.10) min，P<0.001）。RCA组的尿素清除指数（Kt/V）与生理盐水冲洗组相当，差异无统计学意义（1.12±0.34 vs. 1.08±0.34，P=0.41）。

结论

与生理盐水冲洗相比较，双段法枸橼酸联合序贯抗凝能显著减少体外循环凝血事件，延长透析时间，且未观察到严重不良事件发生。