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