Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.]
 injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the
 prevention of Venous Thromboembolic Events [VTE] in patients undergoing hip fracture surgery.

 The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip
 fracture surgery, and to document AVE5026 exposure in this population.
Randomization had to take place just prior to the first study drug injection (randomization
 ratio 1:1).

 The total duration of observation per participant was 35-42 days from surgery broken down as
 follows:

 -  7 to 10-day double-blind treatment period;

 -  28 to 35-day follow-up period.

 Mandatory bilateral venography of the lower limbs had to be performed between 7 to 11 days
 after surgery.
Inclusion Criteria:

 -  Standard surgery for fracture of the upper third of the femur including femoral head
 and neck.

 Exclusion Criteria:

 -  Estimated time of injury/fracture > 24 hours before admission to hospital;

 -  Any major orthopedic surgery in the 3 months prior to study start;

 -  Multiple trauma affecting more than one organ system;

 -  Deep vein thrombosis or pulmonary embolism within the last 12 months or known
 post-phlebitic syndrome;

 -  High risk of bleeding;

 -  Known allergy to heparin, or enoxaparin, or pork products;

 -  End stage renal disease or patient on dialysis;

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.