2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants
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...
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| Vydáno v: | Thrombosis and haemostasis Ročník 121; číslo 8; s. 1008 - 1020 |
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Georg Thieme Verlag KG
01.08.2021
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| Abstract | 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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| AbstractList | 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. 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.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. 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. |
| Author | Gouin-Thibault, Isabelle Guillermo, Cecilia Kitchen, Steve Douxfils, Jonathan Bates, Shannon M. Favaloro, Emmanuel J. Adcock, Dorothy M. Kawai, Yohko Lindhoff-Last, Edelgard Gosselin, Robert C. |
| Author_xml | – sequence: 1 givenname: Jonathan orcidid: 0000-0002-7644-5298 surname: Douxfils fullname: Douxfils, Jonathan email: jonathan.douxfils@unamur.be organization: University of Namur, Department of Pharmacy – sequence: 2 givenname: Dorothy M. surname: Adcock fullname: Adcock, Dorothy M. organization: Laboratory Corporation of America, Burlington North Carolina, United States – sequence: 3 givenname: Shannon M. surname: Bates fullname: Bates, Shannon M. organization: Department of Medicine, McMaster University Medical Centre, Hamilton, Ontario, Canada – sequence: 4 givenname: Emmanuel J. surname: Favaloro fullname: Favaloro, Emmanuel J. organization: Department of Haematology, Sydney Centres for Haemostasis and Thrombosis, Institute of Clinical Pathology and Medical Research, NSW Health Pathology, Westmead Hospital, Westmead, New South Wales, Australia – sequence: 5 givenname: Isabelle surname: Gouin-Thibault fullname: Gouin-Thibault, Isabelle organization: Department of Hematology-Hemostasis, IRSET-INSERM-1085, University Hospital, Rennes, France – sequence: 6 givenname: Cecilia surname: Guillermo fullname: Guillermo, Cecilia organization: Hospital de Clínicas “Dr Manuel Quintela,” Facultad de Medicina, Universidad de la República, Montevideo, Uruguay – sequence: 7 givenname: Yohko surname: Kawai fullname: Kawai, Yohko organization: Sanno Hospital, Laboratory Medicine, Tokyo, Japan – sequence: 8 givenname: Edelgard surname: Lindhoff-Last fullname: Lindhoff-Last, Edelgard organization: Cardiology Angiology Center Bethanien, CCB Vascular Center, CCB Coagulation Center, Frankfurt, Germany – sequence: 9 givenname: Steve surname: Kitchen fullname: Kitchen, Steve organization: Royal Hallamshire Hospital, Coagulation Sheffield, South Yorks, United Kingdom – sequence: 10 givenname: Robert C. orcidid: 0000-0002-5669-8722 surname: Gosselin fullname: Gosselin, Robert C. organization: Hemophilia Treatment Center, University of California, Davis Health System, Sacramento, California, United States |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33742436$$D View this record in MEDLINE/PubMed |
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In 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on... In 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on measuring... |
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| SubjectTerms | Anticoagulation Reversal - standards Blood Coagulation - drug effects Blood Coagulation Tests - standards Consensus Drug Monitoring - standards Evidence-Based Medicine Factor Xa Inhibitors - adverse effects Factor Xa Inhibitors - blood Factor Xa Inhibitors - therapeutic use Hemorrhage - chemically induced Hemorrhage - prevention & control Humans Point-of-Care Testing - standards Predictive Value of Tests Reproducibility of Results Review Article |
| Title | 2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants |
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