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.

Thromboprophylaxis remains a controversial subject. A vast amount of epidemiological and trial data about venous thromboembolism has been published over the past 40 years. These data have been distilled and synthesised into guidelines designed to help the practitioner translate this extensive research into ‘evidence-based’ advice.

Guidelines should, in theory, benefit patient care by ensuring that every patient routinely receives the best prophylaxis; without guidelines, it is argued, patients may fail to receive treatment or be exposed to protocols which are ineffective, dangerous or expensive.

Guidelines, however, have not been welcomed or applied universally. In the United States, orthopaedic surgeons have published their concerns about the thromboprophylaxis guidelines prepared by the American College of Chest Physicians. In Britain, controversy persists with many surgeons unconvinced of the risk/benefit, cost/benefit or practicality of thromboprophylaxis. The extended remit of the recent National Institute of Clinical Excellence thromboprophylaxis guidelines has been challenged.

The reasons for this disquiet are addressed in this paper and particular emphasis is placed on how clinically-acceptable guidelines could be developed and applied.