RECORD 3 Study: Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE; controlled, double-blind, randomized study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement

Not Applicable

Completed

• Conditions: -I82; I82

• Registration Number: PER-049-06
• Lead Sponsor: BAYER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Men and women 18 years of age or older
2. Subjects scheduled for elective surgery of total knee replacement
3. Obtain informed consent in writing from the patient after receiving detailed written and oral information about any specific procedure of the study.

Exclusion Criteria

1. Active bleeding or high risk of hemorrhage as a contraindication to treatment with low molecular weight heparin.
2. Contraindication cited in the package leaflet or conditions that make it impossible to treat the patient with enoxaparin.
3. Conditions that make bilateral phlebography impossible.
4. Pregnant or lactating women. Women of childbearing age who do not use an adequate contraceptive method.
5. Drug or alcohol abuse.
6. Concomitant use of HIV protease inhibitors.
7. Treatment with another product under investigation in the 30 days prior to the start of the study.
8. Intermittent pneumatic compression provided during the treatment period.
9. Simultaneous participation in another trial or study.
10. Other concomitant treatments not allowed.
11. Subjects to whom the anticoagulant therapy can not be interrupted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified