A multicentre randomised clinical endpoint study of parma 5 computer-assisted oral anticoagulant dosage

Leon Poller, Michelle Keown, Saied Ibrahim, Gordon Lowe, Marco Moia, Alexander G. Turpie, Christopher Roberts, Aton M H P Van Den Besselaar, Felix J M Van Der Meer, Armando Tripodi, Gualtiero Palareti, Jørgen Jespersen

Research output: Contribution to journalArticle

Abstract

To meet growing demand for oral anticoagulation worldwide there has been increased dependence on computer-assistance in dosage although the safety and effectiveness of any of the individual computer-assisted dosage programs has not previously been established. This randomised multicentre clinical end-point study assessed a new version of the parma 5 program. It compared parma 5 safety and effectiveness with manual dosage by experienced medical staff at 19 centres with a known interest in oral anticoagulation. Target recruitment was 8000 patient-years, randomised to medical staff or parma-5 assisted dosage. Safety and effectiveness of the parma 5 program was compared with manual dosage. A total of 10 421 patients were recruited (15 369 patient-years) in the 5-year study. International normalised ratio (INR) tests numbered 167 791 with manual and 160 078 with parma 5 dosage. With parma 5 there was overall a non-significant reduction in clinical events but in the 2542 patients with deep vein thrombosis/pulmonary embolism, clinical events were significantly reduced (P = 0.005). Success in achieving 'time in target INR range' was also significantly greater with parma 5 compared with the dosage by experienced medical staff. This study demonstrated the safety and effectiveness of parma 5-assisted dosage.

Original languageEnglish
Pages (from-to)274-283
Number of pages10
JournalBritish Journal of Haematology
Volume143
Issue number2
DOIs
Publication statusPublished - Oct 2008

Keywords

  • Clinical events
  • Computer dosage
  • International normalised ratio
  • Safety and effectiveness
  • Time-in-range

ASJC Scopus subject areas

  • Hematology

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    Poller, L., Keown, M., Ibrahim, S., Lowe, G., Moia, M., Turpie, A. G., Roberts, C., Van Den Besselaar, A. M. H. P., Van Der Meer, F. J. M., Tripodi, A., Palareti, G., & Jespersen, J. (2008). A multicentre randomised clinical endpoint study of parma 5 computer-assisted oral anticoagulant dosage. British Journal of Haematology, 143(2), 274-283. https://doi.org/10.1111/j.1365-2141.2008.07337.x