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

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.

Timeline

Start

2006-05

Primary completion

2007-06

Completion

2007-06

Publications

• Results Lassen MR, Dahl OE, Mismetti P, Destree D, Turpie AG. AVE5026, a new hemisynthetic ultra-low-molecular-weight heparin for the prevention of venous thromboembolism in patients after total knee replacement surgery--TREK: a dose-ranging study. J Thromb Haemost. 2009 Apr;7(4):566-72. doi: 10.1111/j.1538-7836.2009.03301.x. Epub 2009 Jan 24.

Drugs

Indications