title: Extended venous thromboembolism prophylaxis in patients undergoing hip fracture surgery - the SAVE-HIP3 study.
abstract: 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.
authors.affiliation: McGill University Health Centre, 1650 Cedar Avenue, Bureau B5.158.7, Montreal, Quebec H3G 1A4, Canada. wfisher@sympatico.ca
authors.forename: W D
authors.initials: WD
authors.lastname: Fisher
authors.forename: G
authors.initials: G
authors.lastname: Agnelli
authors.forename: D J
authors.initials: DJ
authors.lastname: George
authors.forename: A K
authors.initials: AK
authors.lastname: Kakkar
authors.forename: M R
authors.initials: MR
authors.lastname: Lassen
authors.forename: P
authors.initials: P
authors.lastname: Mismetti
authors.forename: P
authors.initials: P
authors.lastname: Mouret
authors.forename: A G G
authors.initials: AG
authors.lastname: Turpie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054556:Venous Thromboembolism / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; C569346:semuloparin