Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Enoxaparin; Enoxaparin sodium; Heparin, Low-Molecular-Weight; Semuloparin

Criteria

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.