PMID- 33549029
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2224-5839 (Electronic)
IS  - 2224-5820 (Linking)
VI  - 10
IP  - 2
DP  - 2021 Feb
TI  - Evaluating the safety and efficacy of argatroban locking solution in the 
      prevention of the dysfunction of haemodialysis central venous catheters: a study 
      protocol for a randomized controlled trial.
PG  - 2260-2270
LID - 10.21037/apm-20-1641 [doi]
AB  - BACKGROUND: Use of anticoagulant as lock solutions is an important method to 
      maintain the function of haemodialysis (HD) central venous catheters (CVCs), and 
      the common anticoagulants heparin and citrate are not suitable for some patients. 
      Argatroban can inhibit thrombin directly, has a definite anticoagulant effect, 
      and is expected to be a new anticoagulant for CVC lock solutions. METHODS: A 
      total of 60 HD patients with non-tunnelled or tunnelled CVCs will be randomly 
      assigned to two groups: an argatroban group and a control group. The participants 
      will be given argatroban 0.5 mg/mL or unfractionated heparin (UFH) 1,000 U/mL 
      locked post-dialysis instilled into the CVC lumens and followed up for 2 weeks. 
      Data on demographic and general clinical information, laboratory examination, 
      adverse events, adverse reactions and serious adverse events in the two groups 
      will be collected. The differences in coagulation indexes at 30 min following 
      catheter lock will be compared. The thrombosis rate, infection rate and 
      percentage of catheter-days in the two groups will be observed. The primary 
      outcomes include: efficacy assessments of combined outcome events: (I) rates of 
      cumulative catheter survival in the 2-week HD session (the standard of catheter 
      survival was catheter mean blood flow >/=250 mL/min); (II) rates of cumulative 
      survival free of catheter thrombosis in the 2-week HD session. The second 
      outcomes include: catheter dysfunction, the variation value (seconds) in 
      activated partial thromboplastin time (aPTT) at 30 min following catheter locking 
      and aPTT before next dialysis, catheter-associated bleeding, and 
      catheterassociated infections. DISCUSSION: At present, there is no clinical study 
      of argatroban as a CVC lock solution. This study will explore the efficacy and 
      safety of the argatroban as locking solution in the prevention of the dysfunction 
      of HD CVCs to provide evidence for further research. TRIAL REGISTRATION: Chinese 
      Clinical Trial Registry, ChiCTR1800017105. Registered 12 July, 2018 
      (prospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=29054).
FAU - Wang, Yiqin
AU  - Wang Y
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Liu, Chao
AU  - Liu C
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Li, Jijun
AU  - Li J
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Zhang, Lei
AU  - Zhang L
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Wang, Yong
AU  - Wang Y
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Zhu, Hanyu
AU  - Zhu H
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Cao, Xueying
AU  - Cao X
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Wu, Di
AU  - Wu D
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Wu, Jie
AU  - Wu J
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Lin, Shupeng
AU  - Lin S
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Feng, Zhe
AU  - Feng Z
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Cai, Guangyan
AU  - Cai G
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Chen, Xiangmei
AU  - Chen X
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China.
FAU - Sun, Xuefeng
AU  - Sun X
AD  - Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of 
      Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research 
      Center for Kidney Diseases, Beijing, China. xfssun@126.com.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20210125
PL  - China
TA  - Ann Palliat Med
JT  - Annals of palliative medicine
JID - 101585484
RN  - 0 (Pipecolic Acids)
RN  - 0 (Sulfonamides)
RN  - 9005-49-6 (Heparin)
RN  - 94ZLA3W45F (Arginine)
RN  - IY90U61Z3S (argatroban)
SB  - IM
MH  - Arginine/analogs & derivatives
MH  - *Catheter-Related Infections/prevention & control
MH  - *Central Venous Catheters/adverse effects
MH  - Heparin/adverse effects
MH  - Humans
MH  - Pipecolic Acids
MH  - Randomized Controlled Trials as Topic
MH  - Renal Dialysis/adverse effects
MH  - Sulfonamides
OTO - NOTNLM
OT  - Haemodialysis catheters
OT  - argatroban
OT  - unfractionated heparin (UFH)
EDAT- 2021/02/08 06:00
MHDA- 2021/05/15 06:00
CRDT- 2021/02/07 20:25
PHST- 2020/08/19 00:00 [received]
PHST- 2020/12/24 00:00 [accepted]
PHST- 2021/02/08 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2021/02/07 20:25 [entrez]
AID - apm-20-1641 [pii]
AID - 10.21037/apm-20-1641 [doi]
PST - ppublish
SO  - Ann Palliat Med. 2021 Feb;10(2):2260-2270. doi: 10.21037/apm-20-1641. Epub 2021 
      Jan 25.