Ask Stago (english version)

Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation.

In today’s episode, our guest Daniel Pilbeam, from the Clinical Pathology Laboratory at UVet in Melbourne will help us understand the common points and differences between veterinary and human hemostasis, and what should be critically assessed.

Previous episodes in relation to the topic:

•  AskStago episode #9 (season 1): How to manage HIL samples in the coagulation laboratory?

Literature sources:

• John W. Harvey, Veterinary Hematology, Chapter 7 - Evaluation of Hemostasis: Coagulation and Platelet Disorders, W.B. Saunders, 2012, Pages 191-233, ISBN 9781437701739, https://doi.org/10.1016/B978-1-4377-0173-9.00007-5.
• Beurlet S, Coisnon C, Nguyen TT, Richet M, Carlo A, Briend-Marchal A. Comparison of STA-NeoPTimal (Stago) and STA-Neoplastine CI Plus (Stago) thromboplastin reagents using a STA Satellite Max analyzer to measure prothrombin times in dogs. Vet Clin Pathol. 2021 Sep;50(3):348-353. doi: 10.1111/vcp.12949.
• A previous pathologist, Bruce Parry, also co-wrote a paper that was instrumental in identifying cut offs for factor deficiencies that we still use the reference range for today.

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in coagulation.

In today’s episode, our guest Kaitlyn Pelc will explain further the different steps to validate an instrument at the installation.

Previous episodes in relation to the topic:

• S2E18 – Practical check list of the implementation of an instrument in your lab: https://www.podcastics.com/podcast/episode/s2e18-practical-check-list-of-the-implementation-of-an-instrument-in-your-lab-103649/
• S2E3 – How to establish and control the reference range of my assay: https://www.podcastics.com/podcast/episode/s2e3-how-to-establish-and-control-the-reference-range-of-my-assay-60155/
• S2E2 - How to calibrate your reagent as a pro: https://www.podcastics.com/podcast/episode/s2e2-how-to-calibrate-your-reagent-as-a-pro-58249/

Literature sources:

• CLSI. Protocol for the Evaluation, Validation and Implementation of Coagulometers; Approved Guideline. CLSI document H57-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
• CLSI. One-Stage Prothrombin Time (PT-Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline- Second Edition. CLSI document H47-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
• CLSI. Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline. CLSI document H54-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
• CLSI. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition. CLSI document EP28-A3c. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
• CLSI. Measurement Procedure Comparison and Bias Estimation Using Patient Samples. 3rd ed. CLSI guideline EP09c. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
• CLSI. User Verification of Precision and Estimation of Bias; Approved Guideline- Third Edition. CLSI document EP15-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
• College of American Pathologists.  All Common Checklist. Northfield, IL: College of American Pathologists; 2021.

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in hemostasis.

In today’s episode, our guest David Courtois will explain further what is platelet aggregometry, how to measure it and in which indications it is useful.

Literature sources:

• Born GVR. Aggregation of blood platelets by adenosine disphosphate and its reversal. Nature 1962; 194: 927 – 929.
• O’Brien JR. Platelet aggregation. II. Some results from a new method of study. J Clin Pathol 1962; 15: 452-458.
• Caen JP, Michel H. Platelet shape change and aggregation. Nature 1972; 240 (5377): 148-149.
• Holmsen H. Platelet metabolism and activation Semin Hematol. 1985; 22 (3): 2 19-40.
• Kinlough-Rathbone RL, Packham MA, Mustard JF. Platelet aggregation in Methods in Hematology, Churchill Livingstone, New-York 1983; 8: 64-91.
• Zhou L, Schmaier AH. Platelet aggregation testing in platelet-rich plasma: description of procedures with the aim to develop standards in the field. Am J Clin Pathol 2005; 123 (2): 172-183.
• Hvas AM, Favaloro EJ. Platelet function analyzed by light transmission aggregometry. Methods Mol Biol 2017; 1646: 321-331.
• Christie DJ, Avari T, Carrington LR, Cohen E, DeBiase BA, Harrison P, Kickler TS, Kottke-Marchant K, Ledford-Kraemer M, Rand ML, Schmaier AH, McCabe White M. Platelet function testing by aggregometry: approved guidelines, H58-A. Clinical and Laboratory Standards Institute: Wayne, PA, USA 2008; 28 (31): 1-45.
• Frontroth, J.P.; Favaloro, E.J. Ristocetin-Induced Platelet Aggregation (RIPA) and RIPA Mixing Studies. Methods Mol. Biol. 2017, 1646, 473–494.
• Hayward CPM, Pai M, Liu Y, Moffat KA, Seecharan J, Weber KE, Cook RJ, Heddle NM. Diagnostic utility of light transmission platelet aggregometry: results from a prospective study of individuals referred for bleeding disorders assessments. J Throm Haemost 2009; 7 (4): 676-684
• Cattaneo M., Hayward CP, Moffat KA, Pugliano MT, Liu Y, Michelson AD. Results of a worldwide survey on the assessment of platelet function by light transmission aggregometry: a report from the platelet physiology subcommittee of the SSCC of the ISTH. J. Thromb Haemost 2009; 7: 1029
• Hayward CPM, Moffat KA, Raby A, Israels S, Plumhoff E, Flynn G, Zehnder J.L. Development of North American consensus guidelines for medical laboratories that perform and interpret platelet function testing using light transmission aggregometry. Am J Clin Pathol 2010; 134: 955-963.
• Harrison P, Mackie I, Mumford A, Briggs C, Liesner R, Winter M, Machin S. British Committee for Standards in Haematology. Guidelines for the laboratory investigation of heritable disorders of platelet function. Br J Haematol 2011; 155: 30-44
• Dawood BB, Lowe GC, Lordkipanidze M, Bem D, Daly ME, Makris M, Mumford A, Wilde JT, Watson SP. Evaluation of participants with suspected heritable platelet function disorder including recommendation and validation of a streamlined agonist panel. Blood 2012; 120 (25): 5041-5049.
• Cattaneo M, Cerletti C, Harrison P, Hayward CPM, Kenny D, Nugent D, Nurden P, Rao KA, Schmaier AH, Watson SP, Lussana F, Pugliano MT. Recommendations for the standardization of light transmission aggregometry: a consensus of the working party from the platelet physiology subcommittee of SSC/ISTH. J Throm Haemost 2013; 11: 1183-1189.
• Rao AK. Inherited platelet function disorders: overview and disorders of granules, secretion, and signal transduction. Hematol Oncol Clin North Am 2013; 27 (3): 585-611.
• Nurden AT, Nurden P. Inherited disorders of platelet function: selected updates. J Thromb Haemost 2015; 13 (Suppl 1): 2-9.
• Frelinger AL 3rd, Gachet C, Mumford AD, Noris P, Mezzano D, Harrison P, Gresele P. Laboratory monitoring P2Y12 inhibitors communication from the SSC of the ISTH. J Throm Haemost 2018; 16 (11): 2341-2346
• Podda G, Scavone M, Femia EA, Cattaneo M. Aggregometry in the settings of thrombocytopenia, thrombocytosis and antiplatelet therapy. Platelets 2018; 29 (7): 644-649.
• Hayward CPM, Moffat KA, Brunet J, Carlino SA, Plumhoff E, Meijer P, Zehnder JL. Update on diagnostic testing for platelet function disorders: What is pratical and useful? Int J Lab Hematol 2019; 41 (Suppl 1): 26-32
• Gresele P, Orsini S, Noris P, Falcinelli E, Alleci MC, Bury L, Borhany M, Santoro C, Glembotsky AC, Cid AR, Tosetto A, De Candia E, Fontan P, Guglielmini G, Pecci A, BAT-VAL study investigators (57). Validation of the ISTH/SSC bleeding assessment tool for inherited platelet disorders: A communication from the Platelet Physiology SSC. J Thromb Haemost 2020; 18 (3): 732:739.
• Rabbolini D, Connor D, Morel-Kopp MC, Donikian D, Kondo M, Chen W, Alessi MC, Stevenson W, Chen V, Joseph J, Brighton C, Ward C, Sydney Platelet Group. An integrated approach to inherited platelet disorders: results from a research collaborative, the Sydney Platelet Group. Pathology 2020; 52 (2): 243-255.

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in hemostasis.

In today episode, our expert Charlotte Parent, Marketing product manager, will talk with us about the EQA. A valuable tool to ensure the quality of laboratory results.

As usual, don’t forget to send any question you may have to [email protected], we will be glad to answer to it.

Literature sources:

• Ask Stago season 1 episode 3: eIQC and EQA: benefits and differences  https://www.podcastics.com/podcast/episode/3-eiqc-and-eqa-benefits-and-differences-35848/
• ISO 15189:2012, Medical laboratories — Requirements for quality and competence
• ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.<

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in hemostasis.

In today episode, our expert guest, Dr Caroline Vayne from Tours University Hospital in France, gives us an overview on heparin induced thrombocytopenia.

As usual, don’t forget to send any question you may have to [email protected], we will be glad to answer to it.

Learn more:

• Gruel Y, Vayne C, Rollin J, Weber P, Faille D, Bauters A, Macchi L, Alhenc-Gelas M, Lebreton A, De Maistre E, Voisin S, Gouilleux-Gruart V, Perrin J, Tardy-Poncet B, Elalamy I, Lavenu-Bombled C, Mouton C, Biron C, Ternisien C, Nedelec-Gac F, Duchemin J, De Raucourt E, Gouin-Thibault I, Rugeri L, Tardy B, Giraudeau B, Bejan-Angoulvant T, Pouplard C. Comparative Analysis of a French Prospective Series of 144 Patients with Heparin-Induced Thrombocytopenia (FRIGTIH) and the Literature. Thromb Haemost. 2020 Jul;120(7):1096-1107. doi: 10.1055/s-0040-1712957. Epub 2020 Jun 22. PMID: 32572863.
• Gruel Y, De Maistre E, Pouplard C, Mullier F, Susen S, Roullet S, Blais N, Le Gal G, Vincentelli A, Lasne D, Lecompte T, Albaladejo P, Godier A; Members of the French Working Group on Perioperative Haemostasis Groupe d’intérêt en hémostase périopératoire GIHP. Diagnosis and management of heparin-induced thrombocytopenia. Anaesth Crit Care Pain Med. 2020 Apr;39(2):291-310. doi: 10.1016/j.accpm.2020.03.012. Epub 2020 Apr 13. PMID: 32299756.
• Arepally GM. Heparin-induced thrombocytopenia. Blood. 2017 May 25;129(21):2864-2872. doi: 10.1182/blood-2016-11-709873. Epub 2017 Apr 17. PMID: 28416511; PMCID: PMC5445568.
• Rollin J, Pouplard C, Gruel Y. Risk factors for heparin-induced thrombocytopenia: Focus on Fcγ receptors. Thromb Haemost. 2016 Oct 28;116(5):799-805. doi: 10.1160/TH16-02-0109. Epub 2016 Jun 30. PMID: 27358188.
• Pishko AM, Cuker A. Diagnosing heparin-induced thrombocytopenia: The need for accuracy and speed. Int J Lab Hematol. 2021 Jul;43 Suppl 1:96-102. doi: 10.1111/ijlh.13564. PMID: 34288442.
• Tardy B, Lecompte T, Mullier F, Vayne C, Pouplard C. Detection of Platelet-Activating Antibodies Associated with Heparin-Induced Thrombocytopenia. J Clin Med. 2020 Apr 24;9(4):1226. doi: 10.3390/jcm9041226. PMID: 32344682; PMCID: PMC7230370.
• Cuker A, Arepally GM, Chong BH, Cines DB, Greinacher A, Gruel Y, Linkins LA, Rodner SB, Selleng S, Warkentin TE, Wex A, Mustafa RA, Morgan RL, Santesso N. American Society of Hematology 2018 guidelines for management of venous thromboembolism: heparin-induced thrombocytopenia. Blood Adv. 2018 Nov 27;2(22):3360-3392. doi: 10.1182/bloodadvances.2018024489. PMID: 30482768; PMCID: PMC6258919.
• Vayne C, Rollin J, Gruel Y, Pouplard C, Galinat H, Huet O, Mémier V, Geeraerts T, Marlu R, Pernod G, Mourey G, Fournel A, Cordonnier C, Susen S. PF4 Immunoassays in Vaccine-Induced Thrombotic Thrombocytopenia. N Engl J Med. 2021 Jul 22;385(4):376-378. doi: 10.1056/NEJMc2106383. Epub 2021 May 19. PMID: 34010527; PMCID: PMC8174029.
• Pavord S, Scully M, Hunt BJ, Lester W, Bagot C, Craven B, Rampotas A, Ambler G, Makris M. Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis. N Engl J Med. 2021 Oct 28;385(18):1680-1689. doi: 10.1056/NEJMoa2109908. Epub 2021 Aug 11. PMID: 34379914.
• Kizlik-Masson C, Vayne C, McKenzie SE, Poupon A, Zhou Y, Champier G, Pouplard C, Gruel Y, Rollin J. 5B9, a monoclonal antiplatelet factor 4/heparin IgG with a human Fc fragment that mimics heparin-induced thrombocytopenia antibodies. J Thromb Haemost 2017; 15: 2065–75.

Related podcast:

• Understand the sensitivity and specificity https://www.podcastics.com/podcast/episode/8-what-are-sensitivity-and-specificity-performances-of-a-diagnostic-assay-37747/

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation.

In today’s episode, our co-host Audrey Carlo will share her understanding on what is HTA and why Value of Diagnostic Information should be further recognized.

Literature sources:

• Wurcel V, Cicchetti A, Garrison L, Kip MMA, Koffijberg H, Kolbe A, Leeflang MMG, Merlin T, Mestre-Ferrandiz J, Oortwijn W, Oosterwijk C, Tunis S, Zamora B. The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems. Public Health Genomics. 2019;22(1-2):8-15. doi: 10.1159/000501832.
• Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU.
•  Porter ME, Teisberg EO, Redefining Health Care: Creating Value-based Competition on Results, Boston, Mass. : Harvard Business School Press, ©2006.

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation. 

In today’s episode, our expert Pauline Vasselon, US & Projects Registration Coordinator within Stago Market Access team, will provide us the key steps to implement a new instrument in your laboratory.   

Literature sources: 

• ISO 15189 Medical laboratories — Requirements for quality and competence 
• ISO 22870:2010 Intelligent transport systems — Devices to aid reverse manoeuvres — Extended-range backing aid systems (ERBA) 
• CLSI Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition, CLSI document EP09c, Wayne PA, 2018. 
• CLSI Evaluation of Precision of Quantitative Measurement Procedures, Approved guideline, 3rd Edition CLSI document EP05-A3, Wayne PA, 2014. 
• CLSI Evaluation of Linearity of Quantitative Measurement Procedures, 2nd edition, CLSI document EP06, Wayne PA, 2020. 
• CLSI Protocol for the Evaluation, Validation, and Implementation of Coagulometers, Approved Guideline, CLSI document H57-A, Wayne PA, 2008. 

Related podcasts:  

Uncertainty of measurement -

https://www.podcastics.com/podcast/episode/s2e12-demystifying-measurement-uncertainty-78471/

Manage lot conversion -

https://www.podcastics.com/podcast/episode/s2e10-how-to-manage-lot-conversion-in-your-daily-lab-management-75049/

Manage your pre-analyticals -

https://www.podcastics.com/podcast/episode/s2e5-how-to-collect-and-prepare-the-coagulation-samples-properly-67393/

Control the reference ranges of your method -

https://www.podcastics.com/podcast/episode/s2e3-how-to-establish-and-control-the-reference-range-of-my-assay-60155/

Manage HIL interferences -

https://www.podcastics.com/podcast/episode/9-how-to-manage-hil-samples-in-the-coagulation-laboratory-37748/

Understand the sensitivity and specificity -

https://www.podcastics.com/podcast/episode/8-what-are-sensitivity-and-specificity-performances-of-a-diagnostic-assay-37747/

Calculate your MNPT - 

https://www.podcastics.com/podcast/episode/7-how-to-determine-the-mean-normal-prothrombin-time-37746/

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in hemostasis.

In today episode, our expert guest, Dr Stephan Moll, will give a hint of his webinar entitled “The Patient with Venous Thrombosis – Practical Points for the Laboratorian and the Clinician”.

As usual, don’t forget to send any question you may have to [email protected], we will be glad to answer to it.

Learn more:

• Detailed DVT/PE brochure for patients: Moll S, Waldron B. DVT and PE: Information for newly diagnosed patients. Clot Connect brochure for patients. https://clotconnect.wpcomstaging.com/wp-content/uploads/2020/03/dvt_and_pe.pdf
• Condensed DVT/PE information for patients: Waldron B, Moll S. Guide to recovery after deep vein thrombosis or pulmonary embolism. Circulation 2014;129:e477-e479.
• Link to Dr Moll’s webinar:  https://www.labroots.com/ms/webinar/patient-venous-thrombosis-practical-laboratorian-clinician

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in hemostasis. 

In today episode, our expert guest, Jonathan Douxfils, CEO at QUALIblood SA and Professor at the University of Namur / Department of Pharmacy, will detail with us the current recommendation on how to measure direct oral anticoagulants and in which clinical situation this information is relevant and useful..  

As usual, don’t forget to send any question you may have to [email protected], we will be glad to answer to it. 

Learn more - Literature sources: 

• Bernier M, Lancrerot SL, Parassol N, Lavrut T, Viotti J, Rocher F, Drici MD. Therapeutic Drug Monitoring of Direct Oral Anticoagulants May Increase Their Benefit-Risk Ratio. J Cardiovasc Pharmacol. 2020 Oct;76(4):472-477. Epub 2020/10/09. doi:10.1097/FJC.0000000000000870. Cited in: Pubmed; PMID 33030858. 
• Douxfils J, Ageno W, Samama CM, Lessire S, Ten Cate H, Verhamme P, Dogne JM, Mullier F. Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. Journal of thrombosis and haemostasis : JTH. 2018 Feb;16(2):209-219. Epub 2017/12/02. doi:10.1111/jth.13912. Cited in: Pubmed; PMID 29193737. 
• Douxfils J, Mullier F, Dogne JM. Dose tailoring of dabigatran etexilate: obvious or excessive? Expert Opin Drug Saf. 2015 Aug;14(8):1283-9. Epub 2015/05/23. doi:10.1517/14740338.2015.1049995. Cited in: Pubmed; PMID 25994994. 
• Gosselin RC, Adcock DM, Bates SM, Douxfils J, Favaloro EJ, Gouin-Thibault I, Guillermo C, Kawai Y, Lindhoff-Last E, Kitchen S. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thrombosis and haemostasis. 2018 Mar;118(3):437-450. Epub 2018/02/13. doi:10.1055/s-0038-1627480. Cited in: Pubmed; PMID 29433148. 
• Gosselin RC, Adcock DM, Douxfils J. An update on laboratory assessment for direct oral anticoagulants (DOACs). International journal of laboratory hematology. 2019 May;41 Suppl 1(00):33-39. Epub 2019/05/10. doi:10.1111/ijlh.12992. Cited in: Pubmed; PMID 31069969. 
• Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD. To measure or not to measure direct oral anticoagulants before surgery or invasive procedures: comment. Journal of thrombosis and haemostasis : JTH. 2016 Dec;14(12):2556-2559. Epub 2016/10/25. doi:10.1111/jth.13505. Cited in: Pubmed; PMID 27622661. 
• Tripodi A. To measure or not to measure direct oral anticoagulants before surgery or invasive procedures: reply. Journal of thrombosis and haemostasis : JTH. 2016 Dec;14(12):2559-2561. Epub 2016/10/25. doi:10.1111/jth.13513. Cited in: Pubmed; PMID 27662099. 
• Tripodi A. To measure or not to measure direct oral anticoagulants before surgery or invasive procedures. Journal of thrombosis and haemostasis : JTH. 2016 Jul;14(7):1325-7. Epub 2016/04/21. doi:10.1111/jth.13344. Cited in: Pubmed; PMID 27094864 
• Douxfils J, Adcock DM, Bates SM, Favaloro EJ, Gouin-Thibault I, Guillermo C, Kawai Y, Lindhoff-Last E, Kitchen S, Gosselin RC. 2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thrombosis and haemostasis. 2021 Mar 19. Epub 2021/03/21. doi:10.1055/a-1450-8178. Cited in: Pubmed; PMID 33742436. 
• Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L, Investigators R-L. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). Journal of the American College of Cardiology. 2014 Feb 4;63(4):321-8. Epub 2013/10/01. doi:10.1016/j.jacc.2013.07.104. Cited in: Pubmed; PMID 24076487. 
• Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. The Lancet. 2015;385(9984):2288-2295. doi:10.1016/s0140-6736(14)61943-7. 
• Eikelboom JW, Quinlan DJ, Hirsh J, Connolly SJ, Weitz JI. Laboratory Monitoring of Non-Vitamin K Antagonist Oral Anticoagulant Use in Patients With Atrial Fibrillation: A Review. JAMA Cardiol. 2017 May 1;2(5):566-574. Epub 2017/03/30. doi:10.1001/jamacardio.2017.0364. Cited in: Pubmed; PMID 28355459. 
• Bouget J, Oger E. Emergency admissions for major haemorrhage associated with direct oral anticoagulants. Thrombosis research. 2015 Dec;136(6):1190-4. Epub 2015/11/08. doi:10.1016/j.thromres.2015.10.036. Cited in: Pubmed; PMID 26545315. 
• Pollack CV, Jr., Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. The New England journal of medicine. 2017 Aug 3;377(5):431-441. Epub 2017/07/12. doi:10.1056/NEJMoa1707278. Cited in: Pubmed; PMID 28693366. 
• Sennesael AL, Larock AS, Douxfils J, Elens L, Stillemans G, Wiesen M, Taubert M, Dogne JM, Spinewine A, Mullier F. Rivaroxaban plasma levels in patients admitted for bleeding events: insights from a prospective study. Thrombosis journal. 2018;16:28. Epub 2018/11/21. doi:10.1186/s12959-018-0183-3. Cited in: Pubmed; PMID 30455596. 
• Testa S, Legnani C, Antonucci E, Paoletti O, Dellanoce C, Cosmi B, Pengo V, Poli D, Morandini R, Testa R, Tripodi A, Palareti G, Coordinator of SR. Drug levels and bleeding complications in atrial fibrillation patients treated with direct oral anticoagulants. Journal of thrombosis and haemostasis : JTH. 2019 Jul;17(7):1064-1072. Epub 2019/04/24. doi:10.1111/jth.14457. Cited in: Pubmed; PMID 31013383. 
• Testa S, Paoletti O, Legnani C, Dellanoce C, Antonucci E, Cosmi B, Pengo V, Poli D, Morandini R, Testa R, Tripodi A, Palareti G. Low drug levels and thrombotic complications in high-risk atrial fibrillation patients treated with direct oral anticoagulants. Journal of thrombosis and haemostasis : JTH. 2018 May;16(5):842-848. Epub 2018/03/14. doi:10.1111/jth.14001. Cited in: Pubmed; PMID 29532628. 
• Suwa M, Morii I, Kino M. Rivaroxaban or Apixaban for Non-Valvular Atrial Fibrillation- Efficacy and Safety of Off-Label Under-Dosing According to Plasma Concentration. Circ J. 2019 Apr 25;83(5):991-999. Epub 2019/03/29. doi:10.1253/circj.CJ-18-1282. Cited in: Pubmed; PMID 30918237. 
• Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Vanassche T, Potpara T, Camm AJ, Heidbuchel H, External r, Lip GYH, Deneke T, Dagres N, Boriani G, Chao TF, Choi EK, Hills MT, Santos IS, Lane DA, Atar D, Joung B, Cole OM, Field M. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2021 Apr 25. Epub 2021/04/26. doi:10.1093/europace/euab065. Cited in: Pubmed; PMID 33895845. 
• Seiffge DJ, Traenka C, Polymeris AA, Thilemann S, Wagner B, Hert L, Muller MD, Gensicke H, Peters N, Nickel CH, Stippich C, Sutter R, Marsch S, Fisch U, Guzman R, De Marchis GM, Lyrer PA, Bonati LH, Tsakiris DA, Engelter ST. Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice. J Stroke. 2017 Sep;19(3):347-355. Epub 2017/09/08. doi:10.5853/jos.2017.00395. Cited in: Pubmed; PMID 28877563. 
• Steiner T, Bohm M, Dichgans M, Diener HC, Ell C, Endres M, Epple C, Grond M, Laufs U, Nickenig G, Riess H, Rother J, Schellinger PD, Spannagl M, Veltkamp R. Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban. Clin Res Cardiol. 2013 Jun;102(6):399-412. Epub 2013/05/15. doi:10.1007/s00392-013-0560-7. Cited in: Pubmed; PMID 23669868. 
• Levy JH, Ageno W, Chan NC, Crowther M, Verhamme P, Weitz JI, Subcommittee on Control of A. When and how to use antidotes for the reversal of direct oral anticoagulants: guidance from the SSC of the ISTH. Journal of thrombosis and haemostasis : JTH. 2016 Mar;14(3):623-7. Epub 2016/02/26. doi:10.1111/jth.13227. Cited in: Pubmed; PMID 26911798. 
• Martin K, Beyer-Westendorf J, Davidson BL, Huisman MV, Sandset PM, Moll S. Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH. Journal of thrombosis and haemostasis : JTH. 2016 Jun;14(6):1308-13. Epub 2016/06/15. doi:10.1111/jth.13323. Cited in: Pubmed; PMID 27299806. 
• Piran S, Traquair H, Chan N, Bhagirath V, Schulman S. Peak plasma concentration of direct oral anticoagulants in obese patients weighing over 120 kilograms: A retrospective study. Res Pract Thromb Haemost. 2018 Oct;2(4):684-688. Epub 2018/10/24. doi:10.1002/rth2.12146. Cited in: Pubmed; PMID 30349887. 
• Siriez R, Dogne JM, Gosselin R, Laloy J, Mullier F, Douxfils J. Comprehensive review of the impact of direct oral anticoagulants on thrombophilia diagnostic tests: Practical recommendations for the laboratory. International journal of laboratory hematology. 2021 Feb;43(1):7-20. Epub 2020/09/19. doi:10.1111/ijlh.13342. Cited in: Pubmed; PMID 32946681. 
   

Qualiblood website: https://www.qualiblood.eu

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice. 

Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in haemostasis. 
In today episode, our expert Arnaud Rouvière, Global process – Service manager, will provide us all the current recommendations to establish your Quality control ranges.  

As usual, don’t forget to send any question you may have to [email protected], we will be glad to answer to it. 

Learn more  - Previous mentioned podcast  :

• Previous episode with Arnaud Rouvière : S1E7 How to determine the mean normal prothrombin time 
• Learn more about the externalization of your Internal quality controls (eIQC) : S1E3 #3 eIQC and EQA: benefits and differences  
• Go further with the episode dedicated to the reagent lot conversion : S2E10 - How to manage lot conversion in your daily lab management? 

Literature sources: 

• CLSI Statistical Quality Control for Quantitative Measurement Procedures: Principles and definitions; 4th ed. CLSI guideline C24. Wayne PA: Clinical and Laboratory Standard Institute, 2016. 
• ISO 15189:2012 – Meical laboratories – requirements for quality and competence 
• College of American Pathologists. All Common Checklist. Northfield, IL: College of American Pathologists; 2020 
• Neufassung der Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen; Rili-BÄK; – Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen. Dtsch Arztebl Int 2014;111:1583–618. English version: Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical laboratory Examinations – Rili-BAEK”. J Lab Med 2015;39:26–69 

Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.