Overview

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)