PMID- 32244368
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 4
DP  - 2020 Mar 31
TI  - A Prospective Pilot Trial to Assess the Efficacy of Argatroban (Argatra((R))) in 
      Critically Ill Patients with Heparin Resistance.
LID - 10.3390/jcm9040963 [doi]
LID - 963
AB  - The current study aims to evaluate whether prophylactic anticoagulation using 
      argatroban or an increased dose of unfractionated heparin (UFH) is effective in 
      achieving the targeted activated partial thromboplastin time (aPTT) of more than 
      45 s in critically ill heparin-resistant (HR) patients. Patients were randomized 
      either to continue receiving an increased dose of UFH, or to be treated with 
      argatroban. The endpoints were defined as achieving an aPTT target of more than 
      45 s at 7 h and 24 h. This clinical trial was registered on clinicaltrials.gov 
      (NCT01734252) and on EudraCT (2012-000487-23). A total of 42 patients, 20 
      patients in the heparin and 22 in the argatroban group, were included. Of the 
      patients with continued heparin treatment 55% achieved the target aPTT at 7 h, 
      while only 40% of this group maintained the target aPTT after 24 h. Of the 
      argatroban group 59% reached the target aPTT at 7 h, while at 24 h 86% of these 
      patients maintained the targeted aPTT. Treatment success at 7 h did not differ 
      between the groups (p = 0.1000), whereas at 24 h argatroban showed significantly 
      greater efficacy (p = 0.0021) than did heparin. Argatroban also worked better in 
      maintaining adequate anticoagulation in the further course of the study. There 
      was no significant difference in the occurrence of bleeding or thromboembolic 
      complications between the treatment groups. In the case of heparin-resistant 
      critically ill patients, argatroban showed greater efficacy than did an increased 
      dose of heparin in achieving adequate anticoagulation at 24 h and in maintaining 
      the targeted aPTT goal throughout the treatment phase.
FAU - Bachler, Mirjam
AU  - Bachler M
AD  - Institute for Sports Medicine, Alpine Medicine and Health Tourism, 
      UMIT-University for Health Sciences, Medical Informatics and Technology, 6060 
      Hall in Tirol, Austria.
FAU - Hell, Tobias
AU  - Hell T
AD  - Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, 
      University of Innsbruck, 6020 Innsbruck, Austria.
FAU - Bosch, Johannes
AU  - Bosch J
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Treml, Benedikt
AU  - Treml B
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Schenk, Bettina
AU  - Schenk B
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Treichl, Benjamin
AU  - Treichl B
AD  - Department of Anaesthesiology and Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Friesenecker, Barbara
AU  - Friesenecker B
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Lorenz, Ingo
AU  - Lorenz I
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Stengg, Daniel
AU  - Stengg D
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Hruby, Stefan
AU  - Hruby S
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Wallner, Bernd
AU  - Wallner B
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
AD  - Department of Anaesthesiology and Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Oswald, Elgar
AU  - Oswald E
AD  - Department of Anaesthesiology and Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Strohle, Mathias
AU  - Strohle M
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
FAU - Niederwanger, Christian
AU  - Niederwanger C
AD  - Department of Pediatrics, Pediatrics I, Intensive Care Unit, Medical University 
      of Innsbruck, 6020 Innsbruck, Austria.
FAU - Irsara, Christian
AU  - Irsara C
AD  - Central Institute for Medical and Chemical Laboratory Diagnostics, Medical 
      University of Innsbruck, 6020 Innsbruck, Austria.
FAU - Fries, Dietmar
AU  - Fries D
AD  - Department of General and Surgical Critical Care Medicine, Medical University of 
      Innsbruck, 6020 Innsbruck, Austria.
LA  - eng
SI  - ClinicalTrials.gov/NCT01734252
GR  - not applicable/Mitsubishi Tanabe Pharma Corporation/
PT  - Journal Article
DEP - 20200331
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7230377
OTO - NOTNLM
OT  - Argatroban
OT  - critical illness
OT  - hemorrhage
OT  - prophylactic anticoagulation
OT  - thrombosis
OT  - unfractionated heparin
COIS- Mirjam Bachler has received research funding and travel grants from LFB 
      Biomedicaments, Baxter GmbH, CSL Behring GmbH, and Mitsubishi Tanabe, as well as 
      non-financial support from TEM International outside the submitted work. Benedikt 
      Treml has received travel grants from Pfizer. Bettina Schenk has received travel 
      grants, and honoraria for speaking or participation at meetings from CSL Behring, 
      BBraun, and Biotest. Dietmar Fries has received study funding, as well as 
      honoraria for consultancy and board activity from Astra Zeneca, AOP orphan, 
      Baxter, Baer, BBraun, Biotest, CSL Behring, Delta Select, Dae Behring, Edwards, 
      Fresenius, Glaxo, Haemoscope, Hemogem, Lilly, LFB, Mitsubishi Pharma, 
      NovoNordisk, Octapharm, Pfizer, and Tem-Innovation outside the submitted work. 
      The other authors (Tobias Hell, Johannes Bosch, Barbara Friesenecker, Benjamin 
      Treichl, Ingo Lorenz, Daniel Stengg, Stefan Hruby, Bernd Wallner, Elgar Oswald, 
      Mathias Strohle, Christian Niederwanger, and Christian Irsara) declared no 
      conflict of interest. The funders had no role in the design of the study; in the 
      collection, analyses, or interpretation of data; in the writing of the 
      manuscript, or in the decision to publish the results.
EDAT- 2020/04/05 06:00
MHDA- 2020/04/05 06:01
PMCR- 2020/03/31
CRDT- 2020/04/05 06:00
PHST- 2020/03/02 00:00 [received]
PHST- 2020/03/21 00:00 [revised]
PHST- 2020/03/27 00:00 [accepted]
PHST- 2020/04/05 06:00 [entrez]
PHST- 2020/04/05 06:00 [pubmed]
PHST- 2020/04/05 06:01 [medline]
PHST- 2020/03/31 00:00 [pmc-release]
AID - jcm9040963 [pii]
AID - jcm-09-00963 [pii]
AID - 10.3390/jcm9040963 [doi]
PST - epublish
SO  - J Clin Med. 2020 Mar 31;9(4):963. doi: 10.3390/jcm9040963.