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A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH08-10-0664
Issue: 2009: 101/3 (Mar) pp. 413-603
Pages: 487-494

A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program

Leon Poller1; Michelle Keown1; Saied Ibrahim1; Gordon Lowe2; Marco Moia3; Alexander G. Turpie4; Christopher Roberts5; Anton M. H. P. van den Besselaar6; Felix J. M. van der Meer7; Armando Tripodi8; Gualtiero Palareti9; Caroline Shiach10; Stirling Bryan11; Meyer Samama12; Michael Burgess-Wilson13; Anthony Heagerty14; Peter MacCallum15; David Wright16; Jørgen Jespersen17; European Action on Anticoagulation (EAA)
1EAA Central Facility, Faculty of Life Sciences, University of Manchester, Oxford Road, Manchester, UK; 2Department of Medicine, Glasgow Royal Infirmary, Glasgow, UK; 3A Bianchi Bonomi, Hemophilia and Thrombosis Center, IRCCS Maggiore Hospital, Milan, Italy; 4McMaster Clinic, Hamilton General Hospital, Hamilton ON, Canada; 5Biostatistics, Health Methodology Research Group, University of Manchester, Oxford Road, Manchester, UK; 6Haemostasis and Thrombosis Research Center, Leiden University Medical Center, Postbus, Leiden, The Netherlands; 7Haemostasis and Thrombosis Research Center, Leiden University Medical Center, Thrombosis Service Leiden, Poortgebouw, Leiden, The Netherlands; 8University and IRCCS Maggiore Hospital, Mangiagalli and Regina Elena Foundation, Milan, Italy; 9Department of Angiology and Blood Coagulation, University Hospital Sant’Orsola-Malpighi, Bologna, Italy; 10Department of Haematology, Manchester Royal Infirmary, Oxford Road, Manchester, UK; 11Health Economics Facility, Health Services Management Centre, University of Birmingham, Birmingham, UK; 12Laboratoire Central D'Hématologie, Hôtel-Dieu de Paris, Paris, France; 13Haematology Department, Northampton General Hospital NHS Trust, Cliftonville, Northampton, UK; 14Department of Medicine, Manchester Royal Infirmary, Oxford Road, Manchester, UK; 15Wolfson Institute of Preventive Medicine, St Bartholomew’s and The Royal London School of Medicine, London, UK; 16Pontefract General Infirmary, Pontefract, West Yorkshire, UK; 17Department of Clinical Biochemistry, Ribe County Hospital, Esbjerg and Department for Thrombosis Research, Institute of Public Health, University of Southern Denmark, Esbjerg, Denmark

Keywords

Safety, warfarin, Computer-dosage, clinical events, DAWN AC

Summary

Computer-assisted oral anticoagulant dosage is being increasingly used to meet growing demands for oral anticoagulation. The DAWN AC is one of the most widely used computer-dosage programs. Evidence of its value and that of other computer programs has been based previously only on laboratory evidence of “time in target INR range” (TIR) not on clinical safety in practice. A five-year international randomised clinical study of computer assistance with the DAWN AC program compared with manual dosage in 2,631 patients has been performed at 13 centres with established expertise in oral anticoagulation mainly in the EU. Safety assessment have been based on the comparison of bleeding or thrombotic events with DAWN AC compared with manual dosage in a randomised study. Safety of the DAWN AC program has been demonstrated. Clinical events of bleeding and thrombosis were almost identical with the experienced manual dosage group. Therapeutic control improved with DAWN AC to 66.8% from 63.4% TIR. The program failed to provide a dosage recommendation on only 5.7% of occasions. At a group of experienced centres with a special interest in oral anticoagulation, the DAWN AC computer-dosage program proved as safe clinically as manual dosage by experienced medical staff. With DAWN AC, laboratory control was improved, the difference being highly significant. The results should reassure hospitals and community clinics that the DAWN AC program is safe and facilitate greater and longer provision of warfarin treatment where required.

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