Vandenbosch Ines, Dejongh Sander, Claes Kathleen, Bammens Bert, De Vusser Katrien, Van Craenenbroeck Amaryllis, Kuypers Dirk, Evenepoel Pieter, Meijers Björn
Nephrology Unit, Ziekenhuizen Gasthuiszusters, Antwerpen, Belgium.
Division of Nephrology, UZ Leuven, Leuven, Belgium.
Clin Kidney J. 2020 Nov 28;14(8):1901-1907. doi: 10.1093/ckj/sfaa228. eCollection 2021 Aug.
In haemodialysis, maintaining patency of the extracorporeal circuit requires the use of anticoagulants. Although (low molecular weight) heparins are the mainstay, these are not well tolerated in all patients. Alternative approaches include saline infusion, citrate-containing dialysate, regional citrate anticoagulation or the use of heparin-coated membranes. Asymmetric cellulose triacetate (ATA) dialysers have a low degree of platelet contact activation and might be an alternative to heparin-coated dialysers. The aim of this study was to test the clotting propensity of ATA when used without systemic anticoagulation.
We performed a Phase II pilot study in maintenance dialysis patients. The 'Strategies for Asymmetrical Triacetate dialyzer heparin-Free Effective hemodialysis' (SAFE) study was a two-arm open-label crossover study. In Arm A, patients were dialysed using 1.9 m ATA membranes in combination with a citrate-containing dialysate (1 mM). In Arm B, the ATA membrane was combined with high-volume predilution haemodiafiltration (HDF) without any other anticoagulation. The primary endpoint was the success rate to complete 4 h of haemodialysis without preterm clotting. Secondary endpoints included time to clotting and measures of dialysis adequacy.
We scheduled 240 dialysis sessions (120/arm) in 20 patients. Patients were randomized 1:1 to start with Arm A or B. All patients crossed to the other arm halfway through the study. A total of 232 (96.7%) study treatments were delivered. Overall, 23 clotting events occurred, 7 in Arm A and 16 in Arm B. The success rate in Arm A (ATA + citrate-containing dialysate) was 90.8/94.0% [intention to treat (ITT)/as treated]. The success rate in Arm B (ATA + predilution HDF) was 83.3/86.2% (ITT/as treated). Time to clotting was borderline significantly better in Arm A (Mantel-Cox log rank P = 0.05).
ATA dialysers have a low clotting propensity and both predilution HDF and a citrate-containing dialysate resulted in high rates of completed dialysis sessions.
在血液透析中，维持体外循环的通畅需要使用抗凝剂。虽然（低分子量）肝素是主要药物，但并非所有患者都能很好地耐受。其他方法包括生理盐水输注、含柠檬酸盐的透析液、局部柠檬酸盐抗凝或使用肝素涂层膜。不对称三醋酸纤维素（ATA）透析器的血小板接触活化程度较低，可能是肝素涂层透析器的一种替代选择。本研究的目的是测试在不进行全身抗凝的情况下使用ATA时的凝血倾向。
我们对维持性透析患者进行了一项II期试点研究。“不对称三醋酸纤维素透析器无肝素有效血液透析策略”（SAFE）研究是一项双臂开放标签交叉研究。在A组中，患者使用1.9米的ATA膜结合含柠檬酸盐的透析液（1毫摩尔）进行透析。在B组中，ATA膜与高容量预稀释血液透析滤过（HDF）联合使用，不使用任何其他抗凝剂。主要终点是在不提前凝血的情况下完成4小时血液透析的成功率。次要终点包括凝血时间和透析充分性指标。
我们为20名患者安排了240次透析疗程（每组120次）。患者按1:1随机分组，从A组或B组开始。所有患者在研究进行到一半时交叉到另一组。共进行了232次（96.7%）研究治疗。总体而言，发生了23次凝血事件，A组7次，B组16次。A组（ATA+含柠檬酸盐的透析液）的成功率为90.8/94.0%[意向性治疗（ITT）/实际治疗]。B组（ATA+预稀释HDF）的成功率为83.3/86.2%（ITT/实际治疗）。A组的凝血时间在临界值上明显更好（Mantel-Cox对数秩检验P=0.05）。
ATA透析器的凝血倾向较低，预稀释HDF和含柠檬酸盐的透析液均导致较高的透析疗程完成率。
