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Review
. 2021 Aug;121(8):1008-1020.
doi: 10.1055/a-1450-8178. Epub 2021 May 30.

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Jonathan Douxfils  1   2 , Dorothy M Adcock  3 , Shannon M Bates  4 , Emmanuel J Favaloro  5 , Isabelle Gouin-Thibault  6 , Cecilia Guillermo  7 , Yohko Kawai  8 , Edelgard Lindhoff-Last  9 , Steve Kitchen  10 , Robert C Gosselin  11
Affiliations
Review

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Jonathan Douxfils et al. Thromb Haemost. 2021 Aug.

Abstract

In 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alfa. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author's personal experience/expert opinion and (3) good laboratory practice.

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Conflict of interest statement

Among the authors, J.D. is the CEO and founder of QUALIblood s.a., a contract research organization manufacturing the DP-Filter, is a co-inventor of the DP-Filter (patent application number: PCT/ET2019/052903) and reports personal fees from Daiichi Sankyo, Mithra Pharmaceuticals, Stago, Roche and Roche Diagnostics outside the submitted work. E.L.-L received lecture fees and consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb-Pfizer, Daiichi Sankyo, Portola, CSL Behring, Leo and Aspen. She received external funds for conducting a clinical contract study from Bayer and Daiichi Sankyo, for a research project that she initiated from Bayer AG, Bristol-Myers Squibb-Pfizer, Daiichi Sankyo and CSL Behring. E.J.F. and S.M.B. have no conflict of interest. I.G.T. received consulting fees from Bayer, Boehringer Ingelheim and Bristol-Myers Squibb-Pfizer. R.C.G. reports personal fees from Diagnostica Grifols, Siemens Healthcare Diagnostics and Diagnostica Stago, and has provided expert testimony on dabigatran and rivaroxaban testing.

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