We chose unstable extra-capsular hip fractures as our study group
because these types of fractures suffer the largest blood loss.
We hypothesised that tranexamic acid (TXA) would reduce total blood
loss (TBL) in extra-capsular fractures of the hip. A single-centre placebo-controlled double-blinded randomised
clinical trial was performed to test the hypothesis on patients
undergoing surgery for extra-capsular hip fractures. For reasons
outside the control of the investigators, the trial was stopped
before reaching the 120 included patients as planned in the protocol. Aims
Patients and Methods
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% Cite this article: