Status:
COMPLETED
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 \[TKR\] su...
Detailed Description
The randomization had to take place before the first study drug injection. The total duration of observation per participant was 27-33 days from surgery broken down as follows: * 4 to 10-day double-...
Eligibility Criteria
Inclusion
- Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT00331838
Start Date
May 1 2006
End Date
June 1 2007
Last Update
January 15 2013
Active Locations (19)
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1
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
2
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
3
Sanofi-Aventis Administrative Office
Santiago, Chile
4
Sanofi-Aventis Administrative Office
Bogotá, Colombia