gms | German Medical Science

14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

15.11. - 16.11.2007, Frankfurt am Main

Results of observational study CHANGE: prophylaxis and therapy of surgery-related complications in orthopaedic and trauma surgery

Meeting Abstract

  • corresponding author R. Bauersachs - Medical Dept. IV Vascular Medicine, Klinikum Darmstadt, Darmstadt
  • K. Berger - MERG, München
  • J. Hankowitz - Gesundheit + Medizin, München
  • K. Langenberg - GlaxoSmith Kline, Antihrombotics, München
  • I. Marzi - Unfallchirurgie, Universität Frankfurt, Frankfurt
  • W. Schramm - Klinik für Anästhesiologie, Universität München, München

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Frankfurt am Main, 15.-16.11.2007. Düsseldorf: German Medical Science GMS Publishing House; 2007. Doc07gaa18

The electronic version of this article is the complete one and can be found online at:

Published: November 12, 2007

© 2007 Bauersachs et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Context: A major issue of outcome research is to close the gap between efficacy from pivotal studies and effectiveness under life conditions. As shown in a worldwide study programme fondaparinux demonstrated a dramatic reduction (<50%) of venous thromboembolism compared to low molecular weight heparin (Enoxaparin) in 7.344 patients undergoing major orthopaedic and traumatic surgery without increasing clinical relevant bleedings [1].

Aim of the study: The aim of the observational CHANGE study was to evaluate the management of prophylaxis of venous thromboembolism with fondaparinux under real life conditions.

Material and method: Observational study in 111 hospitals in Germany. Patients underwent major orthopaedic (hip and knee replacement) or traumatic surgery (hip or pelvic fracture). Complete data sets of 7.787 patients were used for evaluation.

Results: The overall complication rate was 1,67% (n=131, CI: 1,42/1.99) consisting of bleedings: 1,2% (n=94; CI: 0.99/1,47) and venous thromboembolism 0,47% (n=37, CI: 0,34-0,67). No heparin-induced thrombocytopenia was observed. The corresponding complication rates in the 4 pivotal studies were 3,6 % overall complication rate (bleedings 2,7% (n=96) and venous thromboembolism 0,9% (n= 32)). The detailed results will be presented.

Conclusion: The CHANGE study confirms the results of pivotal studies (efficacy) of fondaparinux in patients undergoing major orthopaedic and traumatic surgery under real life conditions (effectiveness).


Turpie AG, Bauer KA, Eriksson BI, Lassen MR. Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med. 2002;162(16):1833-40.