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DVT Prophylaxis in Total Hip Replacement Trial
RECORD 1 Study: Regulation of coagulation in orthopedic surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59- 7939 in the extended prevention of VTE in patients undergoing elective total hip replacement.
Principal Investigator:
Paul C. Peter, Jr., M.D.
Sub-investigators:
Michael Champine, M.D.
William Tucker, M.D.
Michael Katz, M.D.
Gerhard Maale, M.D.
This clinical trial studies the effectiveness of a new oral medication (BAY 59-7939) for the prevention of Deep Vein Thrombosis (DVT) in patients undergoing elective total hip replacement. It is being compared to an FDA approved medication (enoxaparin sodium) to treat and prevent DVT. Bay 59-7939 is not an FDA approved medication but is being studied to become approved.
Eligibility Criteria (this is not a comprehensive list)
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 (LMWH)
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media, etc)
- Pregnant and breast-feeding women
- Women with child-bearing potential not using adequate birth control method
- Drug or alcohol abuse
- Concomitant use of HIV-protease inhibitors
- Therapy with another investigational product within 30 days prior start of study
- Planned intermittent pneumatic compression during active treatment period
- Concomitant participation in another trial or study
- Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator
- For other concomitant medication not allowed ask the study representative
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