PMID- 31254226
OWN - NLM
STAT- MEDLINE
DCOM- 20200224
LR  - 20200224
IS  - 1619-0904 (Electronic)
IS  - 1434-7229 (Print)
IS  - 1434-7229 (Linking)
VI  - 22
IP  - 4
DP  - 2019 Dec
TI  - Clinical evaluation of performance, biocompatibility, and safety of vitamin 
      E-bonded polysulfone membrane hemodialyzer compared to non-vitamin E-bonded 
      hemodialyzer.
PG  - 307-315
LID - 10.1007/s10047-019-01110-w [doi]
AB  - The vitamin E-bonded polysulfone membrane hemodialyzer (ViE-21) was evaluated in 
      a clinical study for regulatory submission. Seventeen patients on hemodialysis 
      were treated with conventional high-flux hemodialyzers for 2 weeks (Pre-ViE 
      phase) and switched to the ViE-21 for 36 sessions (ViE phase) followed by an 
      additional 2 weeks on conventional hemodialyzers (Post-ViE phase). Reduction 
      ratios of urea, creatinine, beta-2-microglobulin, albumin, and ultrafiltration 
      coefficients (KUF) were measured once during the Pre-ViE phase and twice during 
      the ViE phase. Moreover, biocompatibility markers [leucocyte count, platelet 
      count, and activated complement factor (C3a) levels] were evaluated pre-dialysis, 
      15 min after initiation, and post-dialysis. During the study, type and number of 
      adverse events (AEs), and device malfunctions were recorded. ViE-21 reduction 
      ratios and KUF were not noticeably different than those of conventional 
      hemodialyzers. Fluctuations of leucocyte counts and C3a concentrations were 
      similar using ViE-21 and conventional hemodialyzers; however, the platelet count 
      fluctuation was lower in ViE-21 sessions. The frequency of episodes of 
      hypotension occurring during the ViE phase was lower than that occurring during 
      the Pre- and Post-ViE phases. In conclusion, this study provided performance and 
      safety data of the ViE-21 for regulatory application. The data suggest that 
      vitamin E-bonded hemodialyzers are beneficial in lowering platelet activation and 
      frequency of intradialytic hypotension. Larger randomized controlled trials are 
      needed to confirm these findings.
FAU - Kiaii, Mercedeh
AU  - Kiaii M
AD  - St. Paul'S Hospital, 1081 Burrard Street, Vancouver, BC, Canada.
FAU - Aritomi, Masaharu
AU  - Aritomi M
AUID- ORCID: 0000-0003-3002-8779
AD  - Asahi Kasei Medical Co., Ltd., 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, 
      Japan. aritomi.mb@om.asahi-kasei.co.jp.
FAU - Nagase, Mitsuyo
AU  - Nagase M
AD  - Asahi Kasei Medical Co., Ltd., 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, 
      Japan.
FAU - Farah, Myriam
AU  - Farah M
AD  - St. Paul'S Hospital, 1081 Burrard Street, Vancouver, BC, Canada.
FAU - Jung, Beverly
AU  - Jung B
AD  - St. Paul'S Hospital, 1081 Burrard Street, Vancouver, BC, Canada.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
DEP - 20190626
PL  - Japan
TA  - J Artif Organs
JT  - Journal of artificial organs : the official journal of the Japanese Society for 
      Artificial Organs
JID - 9815648
RN  - 0 (Biocompatible Materials)
RN  - 0 (Biomarkers)
RN  - 0 (Membranes, Artificial)
RN  - 0 (Polymers)
RN  - 0 (Sulfones)
RN  - 0 (beta 2-Microglobulin)
RN  - 1406-18-4 (Vitamin E)
RN  - 25135-51-7 (polysulfone P 1700)
RN  - 8W8T17847W (Urea)
RN  - AYI8EX34EU (Creatinine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Biocompatible Materials/pharmacology
MH  - Biomarkers/blood
MH  - Creatinine/blood
MH  - Female
MH  - Humans
MH  - Kidney Failure, Chronic/metabolism/*therapy
MH  - Male
MH  - Membranes, Artificial
MH  - Middle Aged
MH  - Polymers
MH  - Prospective Studies
MH  - Renal Dialysis/*instrumentation
MH  - Sulfones
MH  - Urea/blood
MH  - Vitamin E/*pharmacology
MH  - Young Adult
MH  - beta 2-Microglobulin/blood
PMC - PMC6861196
OTO - NOTNLM
OT  - Adverse event
OT  - Good clinical practice
OT  - Hemodialysis
OT  - Intradialytic hypotension
OT  - Platelet
COIS- The study was financially supported by Asahi Kasei Medical Co., Ltd. M. Aritomi 
      and M. Nagase are employees of Asahi Kasei Medical Co., Ltd. There are no other 
      conflicts of interests for this study.
EDAT- 2019/06/30 06:00
MHDA- 2020/02/25 06:00
PMCR- 2019/06/26
CRDT- 2019/06/30 06:00
PHST- 2019/04/02 00:00 [received]
PHST- 2019/06/06 00:00 [accepted]
PHST- 2019/06/30 06:00 [pubmed]
PHST- 2020/02/25 06:00 [medline]
PHST- 2019/06/30 06:00 [entrez]
PHST- 2019/06/26 00:00 [pmc-release]
AID - 10.1007/s10047-019-01110-w [pii]
AID - 1110 [pii]
AID - 10.1007/s10047-019-01110-w [doi]
PST - ppublish
SO  - J Artif Organs. 2019 Dec;22(4):307-315. doi: 10.1007/s10047-019-01110-w. Epub 
      2019 Jun 26.