PMID- 27500369
OWN - NLM
STAT- MEDLINE
DCOM- 20170411
LR  - 20181202
IS  - 1879-2472 (Electronic)
IS  - 0049-3848 (Linking)
VI  - 145
DP  - 2016 Sep
TI  - International normalized ratio testing with a point-of-care coagulometer in 
      1-month-old infants: A comparison with Normotest.
PG  - 72-7
LID - S0049-3848(16)30504-7 [pii]
LID - 10.1016/j.thromres.2016.08.004 [doi]
AB  - INTRODUCTION: Early infants are at risk of vitamin K (VK) deficiency-associated 
      bleeding unless they receive VK prophylaxis. A coagulation screening test might 
      be necessary to detect prophylactic failure, but it is rarely conducted owing to 
      the difficulty of blood sampling. CoaguChek XS is a portable, point-of-care (POC) 
      coagulation analyzer that determines international normalized ratios (INRs) using 
      only small volumes of blood. Although POC tests assessing INR have become 
      widespread for adults, studies have not been performed in early infancy. This 
      study aimed to determine the reference interval (RI) for INR for 1-month-old 
      infants using the CoaguChek XS and to compare INRs with Normotest (NT) values to 
      evaluate its efficacy as a VK deficiency screening test. MATERIALS AND METHODS: 
      This study included 578 consecutive 1-month-old, healthy, term infants who 
      underwent a 1-month health checkup. CoaguChek XS INRs and NT values were analyzed 
      for each subject. RESULTS: The enrolled neonates were orally administered VK 
      6-12h and 4days after birth. An INR RI for 1-month-old infants was established 
      using the CoaguChek XS (range of 0.9-1.1). On the other hand, the NT RI was 
      69%-130%. We observed a significant inverse correlation between INRs and NT 
      values. CONCLUSIONS: Our study is the first to establish an INR RI using the 
      CoaguChek XS for 1-month-old, healthy, term infants. CoaguChek XS INR was more 
      convenient to test than NT. However, we could not demonstrate its efficacy as a 
      VK deficiency screening test because no infant had an aberrant NT value or a 
      bleeding disorder.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Iijima, Shigeo
AU  - Iijima S
AD  - Department of Pediatrics, Hamamatsu University School of Medicine, Japan. 
      Electronic address: sige_pd@yahoo.co.jp.
FAU - Baba, Toru
AU  - Baba T
AD  - Department of Pediatrics, Hamamatsu University School of Medicine, Japan. 
      Electronic address: t-baba@hama-med.ac.jp.
FAU - Ueno, Daizo
AU  - Ueno D
AD  - Department of Pediatrics, Hamamatsu University School of Medicine, Japan. 
      Electronic address: daizo_3rd@yahoo.co.jp.
FAU - Ohishi, Akira
AU  - Ohishi A
AD  - Department of Pediatrics, Hamamatsu University School of Medicine, Japan. 
      Electronic address: a-ohishi@hama-med.ac.jp.
LA  - eng
PT  - Journal Article
DEP - 20160803
PL  - United States
TA  - Thromb Res
JT  - Thrombosis research
JID - 0326377
RN  - 0 (Anticoagulants)
SB  - IM
MH  - Anticoagulants/*therapeutic use
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - International Normalized Ratio/*instrumentation/*methods
MH  - Male
MH  - Point-of-Care Systems/*statistics & numerical data
EDAT- 2016/08/09 06:00
MHDA- 2017/04/12 06:00
CRDT- 2016/08/09 06:00
PHST- 2016/06/20 00:00 [received]
PHST- 2016/08/01 00:00 [revised]
PHST- 2016/08/02 00:00 [accepted]
PHST- 2016/08/09 06:00 [entrez]
PHST- 2016/08/09 06:00 [pubmed]
PHST- 2017/04/12 06:00 [medline]
AID - S0049-3848(16)30504-7 [pii]
AID - 10.1016/j.thromres.2016.08.004 [doi]
PST - ppublish
SO  - Thromb Res. 2016 Sep;145:72-7. doi: 10.1016/j.thromres.2016.08.004. Epub 2016 Aug 
      3.