Abstract:
INTRODUCTION:Dabigatran etexilate is an oral direct thrombin inhibitor. Although routine anticoagulation monitoring with dabigatran is not usually required, a simple and precise laboratory test to measure dabigatran concentrations in patient plasma may be useful in certain clinical circumstances, such as emergency situations. The HEMOCLOT(®) Thrombin Inhibitors assay has demonstrated accurate and precise determination of dabigatran concentrations within a range of 50-500 ng/ml. The objective of this study was to assess comparability of dabigatran concentrations determined by HEMOCLOT(®) and by liquid chromatography/tandem mass spectrometry (LC-MS/MS) in plasma samples from human volunteers with end-stage renal disease (ESRD) undergoing regular haemodialysis (HD) during a Phase I study. MATERIALS AND METHODS:Overall, 304 plasma samples were obtained from seven ESRD patients in dabigatran steady-state for measurement by HEMOCLOT(®) (calibrated diluted thrombin time [dTT]) and by LC-MS/MS. Agreement of dabigatran concentrations was assessed by regression analysis and difference plots. RESULTS:The measurements of calibration standards of the HEMOCLOT(®) assay showed excellent precision with coefficients of variation <5%. Accuracy determined by analysis of two quality control samples was 90% and 111%. HEMOCLOT(®)-derived dabigatran plasma concentrations paralleled those obtained by LC-MS/MS. The mean ratio of the LC-MS/MS and dTT-derived concentrations was 0.955 (67% limits of agreement: 0.771-1.18). CONCLUSIONS:The HEMOCLOT(®) Thrombin Inhibitors assay is suitable for measuring dabigatran plasma concentrations in volunteers with ESRD undergoing haemodialysis. The agreement between dabigatran concentrations determined by the HEMOCLOT(®) assay and the LC-MS/MS reference method met bioanalytical acceptance criteria.
journal_name
Thromb Resjournal_title
Thrombosis researchauthors
Schmohl M,Gansser D,Moschetti V,Stangier Jdoi
10.1016/j.thromres.2014.12.021subject
Has Abstractpub_date
2015-03-01 00:00:00pages
532-6issue
3eissn
0049-3848issn
1879-2472pii
S0049-3848(14)00690-2journal_volume
135pub_type
杂志文章abstract::Biological effects of the modification of the sulphate ester and carboxyl group content of poly(vinyl alcohol-acrylic acid) copolymers (PAVAS) and sulphated polyvinyl alcohol copolymers (PVAS) with mol. weight of 5,000 to 20,000 D were studied. The in vitro anticoagulant potency of PAVAS assessed by activated partial ...
journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(94)90154-6
更新日期:1994-05-15 00:00:00
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doi:10.1016/S0049-3848(16)30195-5
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doi:10.1016/s0049-3848(99)00230-3
更新日期:2000-03-15 00:00:00
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journal_title:Thrombosis research
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doi:10.1016/j.thromres.2017.07.006
更新日期:2017-09-01 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(88)90116-8
更新日期:1988-09-01 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章,评审
doi:10.1016/j.thromres.2014.11.034
更新日期:2015-02-01 00:00:00
abstract::Fibrinogen is a hexameric glycoprotein consisting of two sets of three polypeptides (the Aα, Bβ, and γ chains, encoded by the three genes FGA, FGB, and FGG). It is involved in the final phase of the coagulation process, being the precursor of the fibrin monomers necessary for the formation of the hemostatic plug. Rare...
journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2015.05.007
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(87)90428-2
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(88)90359-3
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2008.01.007
更新日期:2008-01-01 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章,评审
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更新日期:2017-07-01 00:00:00
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journal_title:Thrombosis research
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1998-03-15 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(89)90203-x
更新日期:1989-03-01 00:00:00
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pub_type: 杂志文章
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2020.11.039
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journal_title:Thrombosis research
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doi:10.1016/j.thromres.2005.03.025
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journal_title:Thrombosis research
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journal_title:Thrombosis research
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journal_title:Thrombosis research
pub_type: 杂志文章
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更新日期:2003-04-15 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(82)90106-2
更新日期:1982-12-15 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章,评审
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更新日期:2014-05-01 00:00:00
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journal_title:Thrombosis research
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journal_title:Thrombosis research
pub_type: 杂志文章
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journal_title:Thrombosis research
pub_type: 临床试验,杂志文章
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abstract:INTRODUCTION:Cancer is a major risk factor for developing venous thromboembolism (VTE). Plasma hypercoagulability is an established risk factor for cancer-related VTE. In addition, thrombocytosis and hyperreactive platelets have been implicated in VTE and cancer progression. Cirrhosis is associated with changes in plat...
journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2014.11.016
更新日期:2015-02-01 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章
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更新日期:1990-05-15 00:00:00