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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Published in:Thrombosis and haemostasis Vol. 121; no. 8; pp. 1008 - 1020
Main Authors: Douxfils, Jonathan, Adcock, Dorothy M., Bates, Shannon M., Favaloro, Emmanuel J., Gouin-Thibault, Isabelle, Guillermo, Cecilia, Kawai, Yohko, Lindhoff-Last, Edelgard, Kitchen, Steve, Gosselin, Robert C.
Format: Journal Article
Language:English
Published: Rüdigerstraße 14, 70469 Stuttgart, Germany Georg Thieme Verlag KG 01.08.2021
Subjects:
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
diagnosis management
direct oral anticoagulants
guidance
laboratory
ISSN:0340-6245, 2567-689X, 2567-689X
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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.
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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Snippet Abstract 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
URI http://dx.doi.org/10.1055/a-1450-8178
https://www.ncbi.nlm.nih.gov/pubmed/33742436
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