Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee replacement [TKR] surgery.

Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry.

Exclusion Criteria:

• Any major orthopedic surgery in the 3 months prior to study entry;

• Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome;

• Known sensitivity to iodine or contrast dyes;

• Recent stroke or myocardial infarction;

• High risk of bleeding;

• Treatment with other anti-thrombotic agents within 7 days prior to surgery;

• Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin;

• Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method.

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