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.
Regulation of Coagulation in Orthopedic Surgery to prevent Deep Venous Thrombosis and Pulmonary Embolism, controlled, double-blind, randomized study of BAY 59-7939 administered for 5 weeks compared with enoxaparin administered for 10 - 12 days in the extended prevention of Venous Thromboembolism in patients undergoing elective total hip replacement.
Bayer Australia Limited
2,500 participants
Feb 19, 2006
Interventional
Conditions
Summary
The purpose of this study is to assess if 10mg Bay 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
Eligibility
Inclusion Criteria1
- Patients scheduled for elective total hip replacement.- Patients’ written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures.
Exclusion Criteria1
- 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 (amputation of one leg, allergy to contrast media).- 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.
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Interventions
The patients will be randomized to I treatment group. I. 10 mg od of Bay 59-7939 tablets active substance (10 mg tablet) from Day 1 to Day 35 plus a placebo syringe of enoxaparin from Day 0 - Day 12 Day 1 will be defined as the day of the elective total hip replacement. On Day 1 the first dose of BAY 59-7939 or matching placebo and the second dose of enoxaparin or matching placebo will be administered post-operatively 6-8 hours after wound closure. Active treatment period for the Enoxaparin arm is day 0 to day 12. The active treatment period for BAY 59-3979 arm is from Day 1 until day 35. On day 36 a bilateral ascending venography is mandatory for all patients. If symptoms of DVT occur earlier, an ultrasound may be allowed. If the DVT is confirmed by ultrasound, a bilateral ascending venography is mandatory for all patients. No further study medication will be administered after the venography. If symptoms of pulmonary embolism occur during the study (including follow-up of 30 days post study treatment) a lung scintigraphy with chest X-Ray or a spiral CT or a pulmonary angiography should be performed. Symptoms of DVT occurring during follow-up should be verified by ultrasound or venography.
Locations(1)
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ACTRN12606000069550