There is currently limited information available on the benefits and risks of extended thromboprophylaxis after hip fracture surgery. SAVE-HIP3 was a randomised, double-blind study conducted to evaluate the efficacy and safety of extended thromboprophylaxis with the ultra-low molecular-weight heparin semuloparin compared with placebo in patients undergoing hip fracture surgery. After a seven- to ten-day open-label run-in phase with semuloparin (20 mg once daily subcutaneously, initiated post-operatively), patients were randomised to once-daily semuloparin (20 mg subcutaneously) or placebo for 19 to 23 additional days. The primary efficacy endpoint was a composite of any venous thromboembolism (VTE; any deep-vein thrombosis and non-fatal pulmonary embolism) or all-cause death until day 24 of the double-blind period. Safety parameters included major and clinically relevant non-major bleeding, laboratory data, and treatment-emergent adverse events (TEAEs). Extended thromboprophylaxis with semuloparin demonstrated a relative risk reduction of 79% in the rate of any VTE or all-cause death compared with placebo (3.9% vs 18.6%, respectively; odds ratio 0.18 (95% confidence interval 0.07 to 0.45), p < 0.001). Two patients in the semuloparin group and none in the placebo group experienced clinically relevant bleeding. TEAE rates were similar in both groups. In conclusion, the SAVE-HIP3 study results demonstrate that patients undergoing hip fracture surgery benefit from extended thromboprophylaxis.
Cite this article: Bone Joint J 2013;95-B:459–66.
This trial is registered on clinicaltrials.gov: NCT00709904.
The authors received editorial/writing support in the preparation of this manuscript funded by Sanofi, Paris, France. K. Roberts, PhD, of Excerpta Medica, provided the editorial/writing support. M-F. Brégeault, MD, of Sanofi was the Clinical Study Director. This trial was funded by Sanofi.
The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other non-profit organisation with which one or more of the authors are associated.
This article was primary edited by G. Scott and first-proof edited by D. Rowley.
Supplementary material. A further opinion by Ivan Brenkel is available with the electronic version of this article on our website at www.boneandjoint.org.uk/site/education/further_op
- Received August 20, 2012.
- Accepted January 2, 2013.
- ©2013 The British Editorial Society of Bone and Joint Surgery