Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

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

Summary

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.

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

Details

• Lead Sponsor: Bayer
• Treatments: Enoxaparin; Rivaroxaban

Criteria

Inclusion Criteria:

• Male and female patients aged 18 years or above

• Patients scheduled for elective total hip replacement

Exclusion Criteria:

• Planned, staged total bilateral hip replacement

• Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin

• Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin

• Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)