Introduction: Polysulfone (PSf) membrane has been widely used for hemodialysis. A few studies have been reported in which a method of sterilization may affect biocompatibility. In this study, the comparison was made between two PSf membranes in order to evaluate the effect of sterilization from the biocompatibility point of view. Methods: We investigated the biocompatibility of the following two dialyzers, that is, APS‐11SA (Asahi Kasei medical Co., Tokyo, Japan), sterilized by gamma‐ray irradiation, and RENAK PS‐1.0 (Kawasumi laboratories, Tokyo, Japan), sterilized by autoclave. Heparin of 40 units/mL was put in a syringe, and test blood was collected from healthy volunteers. Then, the dialyzer and blood circuit were filled with the test blood. Subsequently, the blood was circulated by a roller pump at the rate of 200 mL/min. We measured the platelet counts, CD41 and CD42b platelet surface markers, beta‐thromboglobulin (beta‐TG) and platelet factor 4 (PF4) at 30, 120, and 240 minutes, respectively. Findings: The platelet counts at 30, 120, and 240 minutes decreased significantly from the initiation of blood circulation in both dialyzers. The average beta‐TG and PF4 increased from 61.3 ± 22.1 and 17.0 ± 6.4 ng/mL to 680.7 ± 217.1 and 550.7 ± 116.7 ng/mL with APS‐11SA and to 454.3 ± 85.6 and 402.0 ± 58.0 ng/mL with RENAK PS‐1.0, respectively. The average expression of CD41 and CD42b in APS‐11SA and RENAK PS‐1.0 was similar. Discussion: There are some reports that the gamma‐ray irradiation changes the membrane structure of the PSf membrane, crosslinking the polyvinylpyrrolidone (PVP), a hydrophilic agent, on to the membrane. On the other hand, excess amount of PVP may have been eluted during the rinsing procedure in RENAK PS‐1.0 because it was sterilized with autoclave. Because both these factors influenced on our results, APS‐11SA and RENAK PS‐1.0 dialyzers showed excellent blood compatibility.
Background: Historically, cellulose-based materials have been used for manufacturing hemodialysis membranes and remain to date as the commonly used materials. Though cellulose triacetate (CTA) membrane originally has a homogeneous structure, recently, CTA membrane with asymmetric structure (ATA®) was developed. By a new spinning technology, irregularities or roughness in the inner surface of ATA have become less than those of the conventional CTA membrane. In this study, a comparison was made between CTA and ATA® membranes in order to evaluate the effect of physical structure of the membrane on the biocompatibility. Methods: We compared the biocompatibility of the following two dialyzers with different triacetate membrane: FB-190UHβ with CTA, and FA-190F with ATA® (both from Nipro, Osaka, Japan). Heparin of 40 units/mL was put in a syringe, and test blood was collected from healthy volunteers. Then, the dialyzer and blood circuit were filled with the test blood. Subsequently, the blood was circulated by a roller pump at the rate of 200 mL/min. We measured the platelet counts, platelet factor 4 (PF4), β-thromboglobulin (β-TG), and CD41 and CD42b platelet surface markers at 30, 120, and 240 min. Results: The average platelet counts at 30, 120, 240 min in CTA and ATA® were similar. The average β-TG and PF4 increased from 87.0 ± 49.0 ng/mL and 30.7 ± 17.3 ng/mL to 1198.5 ± 1017.2 ng/mL and 698.2 ± 574.6 ng/mL with CTA and to 774.3 ± 811.6 ng/mL and 509.0 ± 417.3 ng/mL with ATA®, respectively. The average expression of CD41 and CD42b decreased to 82.8 ± 9.7% and 80.1 ± 11.6% with CTA and 81.9 ± 14.3% and 80.2 ± 13.6% with ATA®, respectively. Conclusions: Observed dialyzers showed less platelet activation as commercial products, and differences between CTA and ATA® were not significant in terms of PF4, β-TG, CD41, and CD42b.
Because hemofilters used for continuous renal replacement therapy contact with blood over a prolonged period during treatments, platelet activation may occur stronger. The purpose of this study is to clarify the blood compatibility in three hemofilters mostly used in Japan. We compared the blood compatibility of the two polysulfone (AEF: Asahi Kasei Medical Co., Tokyo, Japan and SHG: Toray Medical Co., Ltd., Tokyo, Japan) and one polymethylmethacrylate membranes (CH: Toray Medical Co., Ltd.). First, test blood was collected from healthy volunteers. Subsequently, the blood was circulated by a roller pump at the rate of 100 mL/min. We measured the platelet counts and platelet factor 4 (PF4). The platelet counts at 48 h in polymethylmethacrylate membrane were significantly less than that in polysulfone membranes. Levels of the PF4 after the circulation were 978.5 ± 200.0 ng/dL with AEF, 863.0 ± 233.9 ng/dL with SHG and 1780.0 ± 465.1 ng/dL with CH, respectively. Hemofilters with polysulfone membranes showed less platelet activation. It was inferred that the amount of PVP, the smoothness of the membrane surface, and the inner diameter of the hollow fiber affect the blood compatibility in the hemofilter.
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