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Professor dr. med. Jørgen Jespersen, Syddansk Universitet

Clinical and methodological aspects of the haemostatic system – September 2018. Evidensbased medicine. Professor dr. med. Jørgen Jespersen, Syddansk Universitet. Context and prerequisites.

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Professor dr. med. Jørgen Jespersen, Syddansk Universitet

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  1. Clinical and methodological aspects of the haemostatic system – September 2018 Evidensbased medicine Professor dr. med. Jørgen Jespersen, Syddansk Universitet

  2. Context and prerequisites Practicing evidence-based medicine is to integrate individual expertise with the best available external knowledge from systematic research, ie. a clinical discipline Professor Sackett et al. BMJ 1996

  3. Context and prerequisites Quality assurance and standardization of coagulation analyzes

  4. Context and prerequisites Antithrombotic treatment – from laboratory to clinical practice

  5. Context and prerequisites ”Thrombocardiology” – The interface between cardiology and antithrombotic treatment Braunwald E. Foreword. I:Fuster V, Verstrate M, eds. Thrombosis in cardiovascular disorders. Philadelphia: W.B. Saunders 1992: xi-xii Verstrate M, Fuster V, Topol EJ. Cardiovascular Thrombosis. Thrombocardiology and thromboneurology. Eds. Philadelphia: Lippincott-Raven, 1998

  6. Context and prerequisites Evidence -based medicine A love affair or a relevant tool?

  7. Context and prerequisites: Improve health within the budget available for health care Evidence Efficacy QA HCTA Guidelines Effectiveness

  8. Context and prerequisites: Trial culture vs. daily practice culture! Aims: • Narrow • Bridging

  9. Intercenter variation - Dosage

  10. Average results of PT measurements in a group of patients on vitamin K-antagonist treatment. Effects of different thromboplastins

  11. Context and prerequisites Jespersen J: The standardized prothrombin time determination, International Normalized Ratio (INR) and the therapeutic intervals. Ugeskr Læger 1988; 150: 3038-41 Sundhedsstyrelsen: ” Indtil en standardisering har fundet sted, er det Sundhedsstyrelsens opfattelse, at laboratorierne bør lade deres svar ledsage af oplysninger om, hvilket terapeutisk interval, der anbefales ved den i laboratoriet anvendte metode” Ugeskr Læger 1988; 150: 3227

  12. Treatment level expressed in INR. What is INR? • Antikoagulation måles som forlængelse af den Standardiserede protrombintids bestemmelse, hvor koagulationstiden måles efter tilsætning af Ca2+ til citratstabiliseret plasma indeholdende vævstromboplastin (referencetromboplastin). • Graden af antikoagulation måles som forlængelse af koagulationstiden (sekunder) • INR= (PT(patient)/PT(normale))ISI • ISI repræsenterer International Sensitivity Index, der er et mål for et givet vævstromboplastins følsomhed for nedsættelse af aktiviteten af de vitamin K følsomme koagulationsfaktorer • INR defineret i stabil fase af AK-behandling

  13. The advantages of INR • It provides a sound mathematical model for reporting prothrombin time • It improves the reliability of prothrombin time as can be revealed from national an international surveys of prothrombin time assessment • A satisfactory common basis of laboratory control • Allows treatment to be targeted within guidelines • Facilitates the process of consensus with respect to optimal therapeutic ranges • Enables the clinicians to make direct comparison between prothrombin time results regardless of thromboplastin/instrument used • It minimizes any clinical problem that might otherwise occur when a laboratory changes reagents on instrument • It allows uniform guidelines with respect to different invasive procedures performed during long-term anticoagulant treatment Jespersen J. Ugeskr Læger 1988

  14. Kommissorium ”Fastlæggelse af retningslinjer for antikoagulansbehandling og trombocyt-aggregationshæmmende behandling for de hjertesygdomme, hvor denne terapi er indiceret” 1993,1997, 2002, 2006, 2010, 2012 og 2014

  15. Context and prerequisites • Interdisciplinary • Source of material • Documentation levels

  16. National behandlingsplan 2010 Ledende overlæge, lektor ph.d. Lars Hvilsted Rasmussen Ledende overlæge, dr.med. Steen Elkjær Husted Overlæge phd Torben Bjerregaard Larsen Afdelingslæge Erik Grove 1.Reservelæge phd Thomas Decker Christensen Overlæge phd Jens Flensted Lassen Overlæge, professor dr.med Jørgen Jespersen Udarbejdet af en arbejdsgruppe under Dansk Cardiologisk Selskab, Dansk Selskab for Trombose og Hæmostase og Dansk Selskab for Klinisk Biokemi

  17. AK-behandling snævert terapeutisk interval

  18. Kvaliteten af AK-behandling • en klinisk biokemisk analyse af antikoagulansniveauet • en terapeutisk kontrol af behandlingsintensiteten • en klinisk patientkontrol med vurdering af risikofaktorer, bivirkninger og komplikationer

  19. Kvaliteten af AK-behandlingen • Analytiske krav til INR-bestemmelsen: Analyseusikkerhed på < 5%, systematisk afvigelse < +/- 0.2 INR (afvigelse fra sande værdi) • Terapeutiske kontrol: Serielle INR-målinger vurderet i forhold til terapeutisk interval. Stor tilfældig biologisk variation. Totalvariationen (biologiske, præanalytiske og analytiske variation) er estimeret til 14,1 CV%, korresponderende kritiske difference (95%) estimeres til 0.7 INR 2.5 og 1.0 ved INR 3.0 Kjeldsen J, Lassen JF et al. Clin Chem 1997

  20. Diagnostic and Therapeutical Aspects ECAA Clinical and Laboratory Studies Aims and objectives of the ECAA • Standardisation of laboratory monitoring of oral anticoagulants (EU Biomed 1 Programme) • Improvement of clinical dosage (EU Biomed 1 Programme) • Normalisation and standardisation of home prothrombin time monitors (EU Standards, Testing and Measurement Programme) • European Community Quality of Life Programme – Cost effectiveness of computer assisted anticoagulant dosage (EU 2007) • Introduction of POCT and standardisation (EU 2008)

  21. recommendations Recommendations

  22. 100 No. of patients 50 0 Guidelines Thomson et al.BMJ 1998

  23. Context and prerequisites • Interdisciplinary • Source of material • Documentation levels

  24. Context and prerequisites • Interdisciplinary • Source of material • Documentation levels Grilli et al. Lancet 2000

  25. Levels of Evidence:

  26. Grades of Recommendation: (from Shekelle PG, Woolf SH, Eccles M, Grimshaw J.Developing clinical guidelines. West J Med. 170(6):348-51, 1999 June)

  27. CHADS2 :Klinisk tilstand og points (Se Note) Note: Art. hypertension>140/90 mmHg eller behandlet hypertension, dvs i anamnesen NBV 2010

  28. Årlig apopleksirisiko Pisters et al. JAMA 2001 Lip et al. Thromb Haemost 2010

  29. CHADS2 og CHA2DS2-VASc score

  30. HAS-BLED score

  31. Comparative results with warfarin in the RE-LY and EAA studies RE-LY study warfarin arm EAA study of warfarin Patient total 6022 5839 Centres (total) 951 32 Patients per centre 6.3 182.5 Total events per year% Stroke 1.57 0.3 Major bleeding 3.36 0.86 Minor bleeding 16.37 2.7 Deaths 4.13 0.75 Randomised Evaluation of Long-Term Anticoagulation Therapy (RE-LY)

  32. Thank you

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